WO2025009819A1 - Cuttable and consumable tape-type or bar-type preparation enabling drug dose control through length - Google Patents
Cuttable and consumable tape-type or bar-type preparation enabling drug dose control through length Download PDFInfo
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- WO2025009819A1 WO2025009819A1 PCT/KR2024/009183 KR2024009183W WO2025009819A1 WO 2025009819 A1 WO2025009819 A1 WO 2025009819A1 KR 2024009183 W KR2024009183 W KR 2024009183W WO 2025009819 A1 WO2025009819 A1 WO 2025009819A1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/16—Amides, e.g. hydroxamic acids
- A61K31/165—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide
- A61K31/167—Amides, e.g. hydroxamic acids having aromatic rings, e.g. colchicine, atenolol, progabide having the nitrogen of a carboxamide group directly attached to the aromatic ring, e.g. lidocaine, paracetamol
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
Definitions
- the present invention relates to a tape-type or bar-type preparation that can be cut and eaten containing a pharmacologically effective ingredient, and more particularly, to a tape-type or bar-type preparation capable of controlling an accurate drug dosage through the length of the tape or bar; and a method for controlling the drug dosage through the length using the preparation.
- cough syrup is the most suitable formulation for children among the currently available formulations, but there are still several problems that need to be solved.
- Multi-dose containers are a form in which a large volume of medicine is contained in one bottle, and this form of packaging is inconvenient because the syrup must be drained from the bottle and the volume measured each time it is administered. Since it contains a large amount and is usually a heavy bottle, it is not very portable, and there is a possibility that the contents may be contaminated by repeatedly opening and closing the lid.
- Some products use a measuring cup as a lid to make dosing easier, but in this case, washing the cup after administering it to the child becomes a problem.
- single-dose containers are a form in which the amount to be administered once is contained in one packaging container, and since it is used once and thrown away, it reduces the possibility of contamination and provides convenience in administration, but it has another problem. Since the appropriate drug dosage varies depending on the age and weight of the child, if this is not properly controlled, it can lead to overdose or underdose. This can lead to side effects or insufficient treatment of the disease.
- the inventors of the present invention sought to develop a solid dosage form to replace the existing cold medicine syrup having the various problems described above, and as a result, designed a tape-type or bar-type formulation having dividing lines formed at equal intervals along the longitudinal direction.
- a uniform dosage of drug is included according to a certain length, an accurate dosage measurement according to the age and weight of the administration subject (child or adult) is possible, and since it can be easily cut and eaten by hand, and because it is a semi-solid formulation, it has excellent storage stability and is easy to store and carry, thereby completing the present invention.
- the purpose of the present invention is to provide a tape-type or bar-type preparation that can be easily cut and eaten by hand and allows accurate dosage measurement according to the age and weight of the administration subject (child or adult) by forming dividing lines at equal intervals along the longitudinal direction.
- Another object of the present invention is to provide a method for controlling the exact dosage of a drug through length using the tape-type or bar-type preparation.
- a tape-type preparation containing a pharmacologically effective ingredient and having cut lines formed at equal intervals along the length direction is provided.
- the formulation has segments formed at equal intervals along the length, so that the drug dose can be controlled through the length.
- the pharmacologically effective ingredient may include at least one selected from the group consisting of acetaminophen, acetylsalicylic acid, phenylephrine hydrochloride, dextromethorphan hydrobromide hydrate, chlorpheniramine maleate, pseudoephedrine hydrochloride, dl-methylephedrine hydrochloride, dextromethorphan, guaifenesin, chlorperastine hydrochloride, S-ibuprofen, dextromethorphan hydrobromide, noscapine hydrochloride, trimethoquinone hydrochloride, carbetapentane citrate, tipepidine citrate, phenylephedrine hydrochloride, phenylpropanolamine, dexibuprofen, phenacetin, oxymetazoline, chlorperastine phendizoate, d-chlorpheniramine, trip
- the formulation may further include at least one selected from the group consisting of a film forming agent, a plasticizer, a flavoring agent, a flavor modifier, a sweetener, a colorant, a suspending agent, a pH regulator, a nutrient, a lubricant, a preservative, an antiseptic, an emulsifier, a wetting agent, a surfactant, and a buffering agent.
- the present invention provides a method for controlling the dosage of a drug through length using the tape-type preparation.
- the present invention provides a bar type preparation containing a pharmacologically effective ingredient and having cut lines formed at equal intervals along the length direction.
- the formulation has segments formed at equal intervals along the length, so that the drug dose can be controlled through the length.
- the pharmacologically effective ingredient may include at least one selected from the group consisting of acetaminophen, acetylsalicylic acid, phenylephrine hydrochloride, dextromethorphan hydrobromide hydrate, chlorpheniramine maleate, pseudoephedrine hydrochloride, dl-methylephedrine hydrochloride, dextromethorphan, guaifenesin, chlorperastine hydrochloride, S-ibuprofen, dextromethorphan hydrobromide, noscapine hydrochloride, trimethoquinone hydrochloride, carbetapentane citrate, tipepidine citrate, phenylephedrine hydrochloride, phenylpropanolamine, dexibuprofen, phenacetin, oxymetazoline, chlorperastine phendizoate, d-chlorpheniramine, trip
- the formulation may further include at least one selected from the group consisting of a film forming agent, a plasticizer, a flavoring agent, a flavor modifier, a sweetener, a colorant, a suspending agent, a pH regulator, a nutrient, a lubricant, a preservative, an antiseptic, an emulsifier, a wetting agent, a surfactant, and a buffering agent.
- the present invention provides a method for controlling the dosage of a drug through length using the bar type formulation.
- the tape-type or bar-type preparation of the present invention has equidistant cut lines formed along the longitudinal direction, and contains a uniform amount of drug according to a certain length, so that it is possible to accurately measure the dosage according to the age and weight of the medication subject (child or adult) and has the advantage of being able to be easily cut and eaten by hand. That is, in the case of the tape-type or bar-type preparation of the present invention, since the length of the tape or bar and the amount of drug are proportional, the length required to administer an appropriate dosage according to the age and weight of the medication subject (child or adult) can be easily measured and cut, thereby having the advantage of minimizing errors in dosage calculation and reducing side effects.
- the tape-type or bar-type preparation of the present invention is a semi-solid formulation, and unlike a liquid formulation, it is easy to hold and eat without spilling, has excellent storage stability, and has the advantage of being easy to store and carry.
- Figure 1 is a schematic diagram showing a tape-type preparation of the present invention.
- FIG. 2 is a schematic diagram of a tape-type preparation of the present invention, in which dividing lines are marked at equal intervals along the length of the tape to accurately measure dosage according to age and weight (dotted lines: 0.5, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5, 9.5 cm; solid lines: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 cm).
- Figure 3 is a schematic diagram of a bar type preparation with equal intervals marked along the length of the bar to allow for accurate dosage measurement according to age and weight.
- FIG. 4 is a photograph showing a tape-type or bar-type preparation having a jelly formulation manufactured through Example ⁇ 1-1> of the present invention.
- Figure 5 is a photograph showing a bar type preparation having a gummy formulation manufactured through Example ⁇ 1-2> of the present invention.
- the present invention relates to a tape-type or bar-type preparation containing a pharmacologically effective ingredient and having cut lines formed at equal intervals along the longitudinal direction.
- the formulation has segments formed at equal intervals along the length, so that the drug dose can be controlled through the length.
- the tape-type or bar-type preparation of the present invention contains a uniform content of a pharmacologically effective ingredient throughout, and each section formed at equal intervals according to the dosage can be checked and cut to fit the exact dosage.
- Each section can be designed to be cut accurately by inserting a dividing line of a certain length (for example, 0.5 cm or 1.0 cm) for easy division, and even if a dividing line is not inserted, the dosage form itself is soft (flexible), so that the dosage form can be safely divided with just a little force.
- a dividing line of a certain length (for example, 0.5 cm or 1.0 cm) for easy division, and even if a dividing line is not inserted, the dosage form itself is soft (flexible), so that the dosage form can be safely divided with just a little force.
- Each section is marked with cm like a ruler, so that the length can be easily recognized. This method allows the user to easily measure the required amount of drug. This has the effect of greatly improving the inaccurate method of measuring the dosage by taking an appropriate amount of liquid syrup.
- the pharmacologically effective ingredient of the present invention may include an antipyretic, an analgesic or an anti-inflammatory agent as an effective ingredient that can alleviate, improve or treat a cold.
- the pharmacologically effective ingredient may be at least one selected from the group consisting of acetaminophen, acetylsalicylic acid, phenylephrine hydrochloride, dextromethorphan hydrobromide hydrate, chlorpheniramine maleate, pseudoephedrine hydrochloride, dl-methylephedrine hydrochloride, dextromethorphan, guaifenesin, chlorperastine hydrochloride, S-ibuprofen, dextromethorphan hydrobromide, noscapine hydrochloride, trimethoquinone hydrochloride, carbetapentane citrate, tipepidine citrate, phenylephedrine hydrochloride, phenylpropanolamine, dexibuprofen, phenacetin, oxymetazoline, chlorperastine phendizoate, d-chlorpheniramine,
- the formulation of the present invention may further contain film forming agents, plasticizers, flavoring agents, flavor modifiers, sweeteners, colorants, suspending agents, pH regulators, nutrients, lubricants, preservatives, antiseptics, emulsifiers, wetting agents, surfactants, salts and/or buffers for osmotic pressure control, and other therapeutically useful substances known in the art.
- the film forming agent may be selected from the group consisting of pullulan, gelatin, pectin, low viscosity pectin, hydroxypropyl methylcellulose, low viscosity hydroxypropyl methylcellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, carboxymethyl cellulose, polyvinyl pyrrolidone, polyvinyl alcohol, polyacrylic acid, methyl methacrylate copolymer, carboxyvinyl polymer, polyethylene glycol, alginic acid, low viscosity alginic acid, sodium alginate, modified starch, casein, whey protein isolate, soy protein isolate, zein, levan, elsinan, gluten, acacia gum, carrageenan, gum arabic, guar gum, locust bean gum, xanthan gum, gellan gum, and agar.
- a plasticizer can be used to control the flexibility of the film, and the plasticizer can be selected from the group consisting of sorbitol, maltitol, xylitol, glycerin, polyethylene glycol, propylene glycol, hydrogenated molasses, starch syrup, glycerin, triacetin, glycerol oleate, sucrose fatty acid ester, and medium-chain fatty acids.
- Flavoring agents in the present invention include compounds and complexed mixtures of these compounds that impart a desired flavor to edible products.
- natural and synthetic flavorings including natural flavorings
- liquid and powdered flavorings include coconut, coffee, chocolate, vanilla, grape, orange, lime, peppermint, licorice, caramel, honey, peanut, walnut, cashew, hazelnut, almond, pineapple, strawberry, raspberry, tropical fruit, cherry, cinnamon, peppermint, wintergreen, spearmint, eucalyptus, and mint, and fruit essences such as apple, pear, peach, strawberry, apricot, raspberry, cherry, pineapple, and plum essences.
- Essential oils include peppermint, spearmint, menthol, eucalyptus, clove oil, bay oil, anais, thyme, cedar leaf oil, nutmeg, and the aforementioned fruit oils.
- the flavor modifier includes a compound known in the field of flavor chemistry that modifies the perception of taste of other compounds, for example, a bitterness masking agent.
- the sweetener may be a sugar-based sweetener, a non-sugar-based sweetener, a high-sweetness artificial sweetener, etc.
- sugar sweeteners may include saccharide-containing ingredients commonly known in the chewing gum art, including but not limited to sucrose, dextrose, maltose, dextrin, trehalose, D-tagatose, dried invert sugar, fructose, levulose, galactose, corn syrup solids, or mixtures thereof, used alone or in combination.
- saccharide-containing ingredients commonly known in the chewing gum art, including but not limited to sucrose, dextrose, maltose, dextrin, trehalose, D-tagatose, dried invert sugar, fructose, levulose, galactose, corn syrup solids, or mixtures thereof, used alone or in combination.
- the non-sugar sweetener may be sorbitol.
- Other useful non-sugar sweeteners include, but are not limited to, other sugar alcohols, such as mannitol, xylitol, hydrogenated starch hydrolysate, maltitol, isomaltol, erythritol, lactitol, and the like, either singly or in mixtures.
- high-potency artificial sweeteners mentioned above can also be used alone or in combination with the above sweeteners.
- Preferred high-potency sweeteners include, but are not limited to, single compounds or combinations of sucralose, aspartame, acesulfame salts, alitame, saccharin and salts thereof, neotame, cyclamic acid and salts thereof, glycyrrhizin, dihydrochalcone, thaumatin, monellin, and stereosides.
- sugar can be used to provide sweetness for medication compliance, but the content of white sugar can be reduced or eliminated by using sweeteners such as xylitol, aspartame, and saccharin as substitutes. By doing so, it is possible to help children maintain healthy teeth and eating habits, and reduce the risk of obesity and other metabolic diseases. If white sugar is completely replaced, it is also possible to design a dosage form that can be administered before bed without brushing teeth.
- sweeteners such as xylitol, aspartame, and saccharin as substitutes.
- the present invention relates to a method for controlling the dosage of a drug through length using the tape-type or bar-type preparation as described above.
- a tape-type or bar-type preparation containing acetaminophen as a pharmacologically active ingredient has sections formed at equal intervals along the length direction, and at this time, each section can contain 16 mg of acetaminophen at intervals of 1 cm.
- the dosage of the drug can be adjusted through the length based on the following criteria.
- the dosage of the drug contained in equal intervals may vary depending on the type, composition, and manufacturing method of the drug.
- Metering through the length of a solid (semi-solid) dosage form enables accurate drug dosage administration, ensuring effective treatment, and at the same time minimizing the side effects of the drug.
- Acetaminophen, glycerol, and sodium carboxymethyl cellulose were purchased from Sigma-Aldrich.
- Ibuprofen was purchased from Tokyo Chemical Industry.
- Gelatin was purchased from Duksan Pure Chemical.
- Xylitol, corn starch, DL-malic acid, natural strawberry flavor powder, grape flavor, red pigment RP, and purple grape color were purchased from ES Food Ingredients.
- the concentration of acetaminophen was analyzed using a Waters HPLC system (Milford, MA, USA) consisting of a 2996 photodiode array detector and a 2695 separation module. A Fortis C18 chromatography column (5 ⁇ m, 4.6 ⁇ 250 mm) was used for the analysis, and the column temperature was maintained at 30°C. Acetaminophen was injected using a 10 ⁇ L HPLC injection volume. The mobile phase consisting of Ph4.7/MeOH (80:20, v/v) was eluted isocratically at a flow rate of 1.0 mL/min. Acetaminophen was detected at a wavelength of 240 nm.
- the concentration of ibuprofen was analyzed using Agilent HPLC 1260 series (Agilent Technologies, USA). A Fortis C18 chromatography column (5 ⁇ m, 4.6 x 250 mm) was used for the analysis, and the column temperature was maintained at 25°C. The HPLC injection volume for ibuprofen was 20 ⁇ L. The mobile phase consisting of MeOH/DW/Phosphoric acid (75:24.7:0.3, v/v) was eluted isocratically at a flow rate of 1.0 mL/min. Ibuprofen was detected at a wavelength of 264 nm.
- the above composition was shaped using a mold and hardened in a refrigerator at 4°C for 24 hours.
- xylitol powder prepared by mixing xylitol/corn starch (95:5, w/w) in a mixer was mixed with the above composition.
- cut lines were formed at even intervals along the length of the jelly.
- composition and content of the jelly formulation of the present invention are shown in detail in Tables 1 and 2 below, and Fig. 4 shows a cold medicine in the jelly formulation actually manufactured.
- Xylitol powder was prepared by mixing xylitol/corn starch/sodium carboxymethyl cellulose (95:5:1, w/w) in a mixer.
- the manufactured xylitol powder was mixed with the above composition, dough was made using a kneader, and then wrapped and stored at room temperature for 24 hours.
- the dough was made into a certain size through a molding machine.
- composition and content of the gummy formulation of the present invention are shown in detail in Tables 1 and 2 below, and Fig. 5 shows a cold medicine in the gummy formulation actually manufactured.
- the drug content for each formulation was determined by mixing 1 cm of each formulation in 20 ml of a solvent consisting of Ph4.7/MeOH (80:20, v/v) at 60°C for 30 minutes, and then filtering the solution to 0.2 ⁇ m.
- the acetaminophen concentration in each formulation was determined using the HPLC described above.
- the drug content of each formulation was determined by mixing 1 cm of each formulation in 20 ml of MeOH at 60°C for 30 minutes, and then filtering the solution to 0.2 ⁇ m.
- the ibuprofen concentration of each formulation was determined using the HPLC described above.
- the length of the formulation to be cut can be set corresponding to the child's weight and age.
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Abstract
Description
본 발명은 약리학적 유효성분을 포함하는 잘라먹을 수 있는 테이프형(tape-type) 또는 바형(bar type) 제제에 관한 것으로, 자세하게는 테이프 또는 바(bar)의 길이를 통해 정확한 약물 용량을 조절 가능한 테이프형(tape-type) 또는 바형(bar type) 제제; 및 상기 제제를 이용하여 길이를 통해 약물의 용량을 조절하는 방법에 관한 것이다.The present invention relates to a tape-type or bar-type preparation that can be cut and eaten containing a pharmacologically effective ingredient, and more particularly, to a tape-type or bar-type preparation capable of controlling an accurate drug dosage through the length of the tape or bar; and a method for controlling the drug dosage through the length using the preparation.
흔히 집에서 상비하는 어린이용 약은 주로 콧물약, 기침약, 해열약, 종합감기약, 항히스타민약 등 여러 가지가 있다. 어린이는 성인과 달리 투여 약물의 용량이 작으며, 알약을 삼키는 데 어려움을 겪는다. 또한 어린이의 나이에 따라 몸무게와 키가 달라 이에 맞춰 용량을 조절해야 할 필요성이 있다. 이러한 이유로 제약사들은 용량 조절이 어려운 알약보다는 부피로 계량이 쉬운 시럽제형을 많이 제공하고 있다. 현재 많이 판매되는 시럽 제형의 나이에 따른 투여 볼륨은 몸무게와 나이에 따라 2.5~20.0 mL로 다양하다. 이렇듯 어린이의 체중과 나이에 따라 용량 차이가 크게 나타나기 때문에 제약사에서 특정 나이에 맞는 맞춤형 제형을 만들기 어렵다는 문제점이 있다.Commonly kept medicines for children at home include nasal drops, cough drops, antipyretics, cold medicines, antihistamines, etc. Unlike adults, children need smaller doses of medications and have difficulty swallowing pills. In addition, the weight and height of children vary depending on their age, so the dosage needs to be adjusted accordingly. For this reason, pharmaceutical companies provide many syrup formulations that are easy to measure by volume rather than tablets that are difficult to adjust the dosage. The dosage volume of syrup formulations currently sold varies from 2.5 to 20.0 mL depending on weight and age. Since the dosage varies greatly depending on the weight and age of the child, there is a problem that it is difficult for pharmaceutical companies to create customized formulations for a specific age.
최근 코프 시럽(cough syrup) 제형의 층 분리, 덩어리 검출 등 문제가 불거지고 있다. 이는 액상 제형의 불안정성 때문이다. 게다가 시럽형의 약은 보관이 어렵고, 액상이기 때문에 고형 제제에 비하여 유통 기한이 짧다. 또한 흘리기 쉽기 때문에 부모님들이 투여할 때 어려움을 겪을 수도 있다. 이처럼 코프 시럽(cough syrup)은 현재 나온 제형 중에는 가장 어린이가 섭취하기에 적합하지만, 여전히 해결해야 할 여러 가지 문제점이 있다.Recently, problems such as layer separation and lump detection in cough syrup formulations have been raised. This is due to the instability of liquid formulations. In addition, syrup-type medicines are difficult to store, and because they are liquid, they have a shorter shelf life than solid formulations. In addition, because they are easy to spill, parents may have difficulty administering them. In this way, cough syrup is the most suitable formulation for children among the currently available formulations, but there are still several problems that need to be solved.
시판되고 있는 시럽 포장 형태는 다회 투여 용기와 단회 투여 용기로 나뉠 수 있다. 다회 투여 용기는 큰 부피의 약을 한 병에 담아놓는 형태로, 이 형태의 포장은 투여 시 매번 병에서 시럽을 따라내어 부피를 계량해야 하는 번거로움이 있다. 많은 양이 들어있고 보통 무거운 병으로 되어 있기 때문에 휴대성도 떨어지며, 뚜껑을 반복적으로 열고 닫음으로써 내용물이 오염될 가능성이 있다. 개량을 쉽게하기 위해 계량용 컵을 뚜껑으로 활용하는 제품도 있지만, 이 경우 아이에게 투여 후 컵의 세척이 문제가 된다. 한편, 단회 투여 용기는 한 번 투여할 분량을 한 포장 용기에 넣는 형태로, 한번 쓰고 버리기 때문에 투여에 있어서 오염의 가능성을 줄이고 편리성을 제공하지만, 또 다른 문제점을 가지고 있다. 아이들의 나이와 체중에 따라 알맞은 약물 용량이 다르기 때문에, 이를 제대로 조절하지 못하면 과다복용이나 미량 복용으로 이어질 수 있다. 이는 부작용이나 질병 치료의 미흡을 초래할 수 있다.The syrup packaging forms currently on the market can be divided into multi-dose containers and single-dose containers. Multi-dose containers are a form in which a large volume of medicine is contained in one bottle, and this form of packaging is inconvenient because the syrup must be drained from the bottle and the volume measured each time it is administered. Since it contains a large amount and is usually a heavy bottle, it is not very portable, and there is a possibility that the contents may be contaminated by repeatedly opening and closing the lid. Some products use a measuring cup as a lid to make dosing easier, but in this case, washing the cup after administering it to the child becomes a problem. On the other hand, single-dose containers are a form in which the amount to be administered once is contained in one packaging container, and since it is used once and thrown away, it reduces the possibility of contamination and provides convenience in administration, but it has another problem. Since the appropriate drug dosage varies depending on the age and weight of the child, if this is not properly controlled, it can lead to overdose or underdose. This can lead to side effects or insufficient treatment of the disease.
따라서 코프 시럽(cough syrup)의 투여와 관련된 위험성은 용량 조절 문제, 약물의 성분 문제, 포장 문제 등 다양한 측면에서 나타나며, 이 모든 문제를 해결하기 위한 새로운 접근 방식이 필요하다.Therefore, the risks associated with administering cough syrup are diverse, including issues with dosage adjustment, drug composition, and packaging, and a new approach is needed to address all of these issues.
이러한 배경 하에, 본 발명자들은 상기와 같은 다양한 문제점을 가지고 있는 기존의 감기약 시럽을 대체할 고형 제형을 개발하고자 하였으며, 그 결과 길이 방향을 따라 등간격으로 할선이 형성된 테이프형(tape-type) 또는 바형(bar type) 제제를 설계하였다. 상기 테이프형(tape-type) 또는 바형(bar type) 제제의 경우 일정 길이에 따른 균일한 용량의 약물이 포함됨으로써 투약 대상(어린이 또는 성인)의 나이 및 체중에 맞춘 정확한 용량 계량이 가능하며, 손으로 쉽게 잘라먹을 수 있으며, 반고형의 제형이므로 저장 안정성이 우수하며, 보관 및 휴대가 용이함을 확인함으로써 본 발명을 완성하였다.Against this backdrop, the inventors of the present invention sought to develop a solid dosage form to replace the existing cold medicine syrup having the various problems described above, and as a result, designed a tape-type or bar-type formulation having dividing lines formed at equal intervals along the longitudinal direction. In the case of the tape-type or bar-type formulation, since a uniform dosage of drug is included according to a certain length, an accurate dosage measurement according to the age and weight of the administration subject (child or adult) is possible, and since it can be easily cut and eaten by hand, and because it is a semi-solid formulation, it has excellent storage stability and is easy to store and carry, thereby completing the present invention.
따라서 본 발명의 목적은 길이 방향을 따라 등간격으로 할선이 형성됨으로써 투약 대상(어린이 또는 성인)의 나이 및 체중에 맞춘 정확한 용량 계량이 가능하며, 손으로 쉽게 잘라먹을 수 있는 테이프형(tape-type) 또는 바형(bar type) 제제를 제공하는 것이다.Accordingly, the purpose of the present invention is to provide a tape-type or bar-type preparation that can be easily cut and eaten by hand and allows accurate dosage measurement according to the age and weight of the administration subject (child or adult) by forming dividing lines at equal intervals along the longitudinal direction.
본 발명의 다른 목적은 상기 테이프형(tape-type) 또는 바형(bar type) 제제를 이용하여 길이를 통해 약물의 정확한 용량을 조절하는 방법 제공하는 것이다.Another object of the present invention is to provide a method for controlling the exact dosage of a drug through length using the tape-type or bar-type preparation.
상기와 같은 본 발명의 목적을 달성하기 위해서,In order to achieve the above purpose of the present invention,
약리학적 유효성분을 포함하고, 길이 방향을 따라 등간격으로 할선이 형성된 테이프형(tape-type) 제제를 제공한다.A tape-type preparation containing a pharmacologically effective ingredient and having cut lines formed at equal intervals along the length direction is provided.
본 발명의 일실시예에 있어서, 상기 제제는 길이방향을 따라 등간격으로 할선이 형성됨으로써 길이를 통해 약물 용량이 조절 가능할 수 있다.In one embodiment of the present invention, the formulation has segments formed at equal intervals along the length, so that the drug dose can be controlled through the length.
본 발명의 일실시예에 있어서, 상기 약리학적 유효성분은 아세트아미노펜, 아세틸살리실산, 페닐레프린염산염, 덱스트로메트로판브롬화수소산염수화물, 클로르페니라민말레산염, 슈도에페드린염산염, dl-메틸에페드린염산염, 덱스트로메토르판, 구아이페네신, 클로페라스틴염산염, S-이부프로펜, 브롬화수소산덱스트로메토르판, 노스카핀염산염, 트리메토퀴논염산염, 구연산카르베타펜탄, 구연산티페피딘, 페닐에페드린염산염, 페닐프로판올 아민, 덱시부프로펜, 페나세틴, 옥시메타졸린, 펜디조산클로페라스틴, d-클로르페니라민, 트리프롤리딘, 카르비녹사민, 페닐레프린 염산염 및 브롬페니라민말레산염제로 이루어진 군에서 선택된 1종 이상을 포함할 수 있다.In one embodiment of the present invention, the pharmacologically effective ingredient may include at least one selected from the group consisting of acetaminophen, acetylsalicylic acid, phenylephrine hydrochloride, dextromethorphan hydrobromide hydrate, chlorpheniramine maleate, pseudoephedrine hydrochloride, dl-methylephedrine hydrochloride, dextromethorphan, guaifenesin, chlorperastine hydrochloride, S-ibuprofen, dextromethorphan hydrobromide, noscapine hydrochloride, trimethoquinone hydrochloride, carbetapentane citrate, tipepidine citrate, phenylephedrine hydrochloride, phenylpropanolamine, dexibuprofen, phenacetin, oxymetazoline, chlorperastine phendizoate, d-chlorpheniramine, triprolidine, carbinoxamine, phenylephrine hydrochloride, and brompheniramine maleate.
본 발명의 일실시예에 있어서, 상기 제제는 필름형성제, 가소제, 착향제, 향미개질제, 감미제, 착색제, 현탁제, pH 조절제, 영양제, 윤활제, 보존제, 방부제, 유화제, 수화제, 계면활성제 및 완충제로 이루어진 군으로부터 선택되는 1종 이상을 더 포함할 수 있다.In one embodiment of the present invention, the formulation may further include at least one selected from the group consisting of a film forming agent, a plasticizer, a flavoring agent, a flavor modifier, a sweetener, a colorant, a suspending agent, a pH regulator, a nutrient, a lubricant, a preservative, an antiseptic, an emulsifier, a wetting agent, a surfactant, and a buffering agent.
또한, 본 발명은 상기 테이프형(tape-type) 제제를 이용하여 길이를 통해 약물의 용량을 조절하는 방법을 제공한다.In addition, the present invention provides a method for controlling the dosage of a drug through length using the tape-type preparation.
또한, 본 발명은 약리학적 유효성분을 포함하고, 길이 방향을 따라 등간격으로 할선이 형성된 바형(bar type) 제제를 제공한다.In addition, the present invention provides a bar type preparation containing a pharmacologically effective ingredient and having cut lines formed at equal intervals along the length direction.
본 발명의 일실시예에 있어서, 상기 제제는 길이방향을 따라 등간격으로 할선이 형성됨으로써 길이를 통해 약물 용량이 조절 가능할 수 있다.In one embodiment of the present invention, the formulation has segments formed at equal intervals along the length, so that the drug dose can be controlled through the length.
본 발명의 일실시예에 있어서, 상기 약리학적 유효성분은 아세트아미노펜, 아세틸살리실산, 페닐레프린염산염, 덱스트로메트로판브롬화수소산염수화물, 클로르페니라민말레산염, 슈도에페드린염산염, dl-메틸에페드린염산염, 덱스트로메토르판, 구아이페네신, 클로페라스틴염산염, S-이부프로펜, 브롬화수소산덱스트로메토르판, 노스카핀염산염, 트리메토퀴논염산염, 구연산카르베타펜탄, 구연산티페피딘, 페닐에페드린염산염, 페닐프로판올 아민, 덱시부프로펜, 페나세틴, 옥시메타졸린, 펜디조산클로페라스틴, d-클로르페니라민, 트리프롤리딘, 카르비녹사민, 페닐레프린 염산염 및 브롬페니라민말레산염제로 이루어진 군에서 선택된 1종 이상을 포함할 수 있다.In one embodiment of the present invention, the pharmacologically effective ingredient may include at least one selected from the group consisting of acetaminophen, acetylsalicylic acid, phenylephrine hydrochloride, dextromethorphan hydrobromide hydrate, chlorpheniramine maleate, pseudoephedrine hydrochloride, dl-methylephedrine hydrochloride, dextromethorphan, guaifenesin, chlorperastine hydrochloride, S-ibuprofen, dextromethorphan hydrobromide, noscapine hydrochloride, trimethoquinone hydrochloride, carbetapentane citrate, tipepidine citrate, phenylephedrine hydrochloride, phenylpropanolamine, dexibuprofen, phenacetin, oxymetazoline, chlorperastine phendizoate, d-chlorpheniramine, triprolidine, carbinoxamine, phenylephrine hydrochloride, and brompheniramine maleate.
본 발명의 일실시예에 있어서, 상기 제제는 필름형성제, 가소제, 착향제, 향미개질제, 감미제, 착색제, 현탁제, pH 조절제, 영양제, 윤활제, 보존제, 방부제, 유화제, 수화제, 계면활성제 및 완충제로 이루어진 군으로부터 선택되는 1종 이상을 더 포함할 수 있다.In one embodiment of the present invention, the formulation may further include at least one selected from the group consisting of a film forming agent, a plasticizer, a flavoring agent, a flavor modifier, a sweetener, a colorant, a suspending agent, a pH regulator, a nutrient, a lubricant, a preservative, an antiseptic, an emulsifier, a wetting agent, a surfactant, and a buffering agent.
또한, 본 발명은 상기 바형(bar type) 제제를 이용하여 길이를 통해 약물의 용량을 조절하는 방법을 제공한다.In addition, the present invention provides a method for controlling the dosage of a drug through length using the bar type formulation.
본 발명의 테이프형(tape-type) 또는 바형(bar type) 제제는 길이 방향을 따라 등간격으로 할선이 형성되어 있으며, 일정 길이에 따른 균일한 용량의 약물이 포함됨으로써 투약 대상(어린이 또는 성인)의 나이 및 체중에 맞춘 정확한 용량 계량이 가능하고 손으로 쉽게 잘라먹을 수 있는 이점을 갖는다. 즉, 본 발명의 테이프형(tape-type) 또는 바형(bar type) 제제의 경우 테이프 또는 바(bar)의 길이와 약 용량은 비례하기 때문에, 투약 대상(어린이 또는 성인)의 나이 및 체중에 따른 적절한 용량을 투여하기 위해 필요한 길이를 쉽게 측정하고 잘라낼 수 있는바, 용량 계산의 오차를 최소화하고 부작용을 줄일 수 있는 이점을 갖는다. 또한, 본 발명의 테이프형(tape-type) 또는 바형(bar type) 제제는 반고형의 제형으로 액상 제형과 달리 흘리지 않고도 잡고 먹기 편하며, 저장 안정성이 우수할 뿐만 아니라, 보관 및 휴대가 용이한 이점을 갖는다.The tape-type or bar-type preparation of the present invention has equidistant cut lines formed along the longitudinal direction, and contains a uniform amount of drug according to a certain length, so that it is possible to accurately measure the dosage according to the age and weight of the medication subject (child or adult) and has the advantage of being able to be easily cut and eaten by hand. That is, in the case of the tape-type or bar-type preparation of the present invention, since the length of the tape or bar and the amount of drug are proportional, the length required to administer an appropriate dosage according to the age and weight of the medication subject (child or adult) can be easily measured and cut, thereby having the advantage of minimizing errors in dosage calculation and reducing side effects. In addition, the tape-type or bar-type preparation of the present invention is a semi-solid formulation, and unlike a liquid formulation, it is easy to hold and eat without spilling, has excellent storage stability, and has the advantage of being easy to store and carry.
도 1은 본 발명의 테이프형(tape-type) 제제를 보여주는 모식도이다.Figure 1 is a schematic diagram showing a tape-type preparation of the present invention.
도 2는 본 발명의 테이프형 제제에 있어서 나이 및 체중에 맞춘 정확한 용량 계량을 위하여 테이프의 길이 방향을 따라 등간격으로 할선을 표시한 테이프형 제제의 모식도이다(점선: 0.5, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5, 9.5 cm, 실선: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 cm).FIG. 2 is a schematic diagram of a tape-type preparation of the present invention, in which dividing lines are marked at equal intervals along the length of the tape to accurately measure dosage according to age and weight (dotted lines: 0.5, 1.5, 2.5, 3.5, 4.5, 5.5, 6.5, 7.5, 8.5, 9.5 cm; solid lines: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 cm).
도 3은 나이 및 체중에 맞춘 정확한 용량 계량을 위하여 바(bar)의 길이 방향을 따라 등간격으로 할선을 표시한 바형(bar type) 제제의 모식도이다.Figure 3 is a schematic diagram of a bar type preparation with equal intervals marked along the length of the bar to allow for accurate dosage measurement according to age and weight.
도 4는 본 발명의 실시예 <1-1>을 통해 제조된 젤리 제형을 갖는 테이프형(tape-type) 또는 바형(bar type) 제제를 보여주는 사진이다.FIG. 4 is a photograph showing a tape-type or bar-type preparation having a jelly formulation manufactured through Example <1-1> of the present invention.
도 5는 본 발명의 실시예 <1-2>를 통해 제조된 구미 제형을 갖는 바형(bar type) 제제를 보여주는 사진이다.Figure 5 is a photograph showing a bar type preparation having a gummy formulation manufactured through Example <1-2> of the present invention.
본 발명은 약리학적 유효성분을 포함하고, 길이 방향을 따라 등간격으로 할선이 형성된 테이프형(tape-type) 또는 바형(bar type) 제제에 관한 것이다.The present invention relates to a tape-type or bar-type preparation containing a pharmacologically effective ingredient and having cut lines formed at equal intervals along the longitudinal direction.
본 발명의 일구체예에서, 상기 제제는 길이 방향을 따라 등간격으로 할선이 형성됨으로써 길이를 통해 약물 용량이 조절 가능하다.In one specific embodiment of the present invention, the formulation has segments formed at equal intervals along the length, so that the drug dose can be controlled through the length.
본 발명의 테이프형(tape-type) 또는 바형(bar type) 제제는 전체적으로 약리학적 유효성분의 함량을 균일하게 포함하고 있는바, 복용량에 따라 등간격으로 형성된 각 구간을 확인하여 정확한 용량에 맞추어 끊어먹을 수 있다.The tape-type or bar-type preparation of the present invention contains a uniform content of a pharmacologically effective ingredient throughout, and each section formed at equal intervals according to the dosage can be checked and cut to fit the exact dosage.
각 구간은 쉽게 나눌 수 있도록 일정 길이(예를 들어 0.5 cm 또는 1.0 cm)의 할선을 넣어 정확하게 자를 수 있게 설계할 수 있고, 할선을 굳이 넣지 않더라도 제형 자체가 무르기 때문에(유연성이 있음) 약간의 힘만으로도 안전하게 제형을 나눌 수 있다. 각 구간에는 자(ruler)처럼 cm가 표시되어 쉽게 길이를 인식할 수 있다. 이 방식을 통해 사용자는 필요한 용량만큼의 약물을 손쉽게 계량할 수 있다. 이는 기존의 액상 시럽을 적당히 덜어내서 용량을 계량했던 부정확한 방식을 크게 개선하는 효과를 가진다.Each section can be designed to be cut accurately by inserting a dividing line of a certain length (for example, 0.5 cm or 1.0 cm) for easy division, and even if a dividing line is not inserted, the dosage form itself is soft (flexible), so that the dosage form can be safely divided with just a little force. Each section is marked with cm like a ruler, so that the length can be easily recognized. This method allows the user to easily measure the required amount of drug. This has the effect of greatly improving the inaccurate method of measuring the dosage by taking an appropriate amount of liquid syrup.
본 발명의 상기 약리학적 유효성분은 감기를 완화, 개선 또는 치료할 수 있는 해열제, 진통제 또는 소염제를 유효성분으로 포함할 수 있다.The pharmacologically effective ingredient of the present invention may include an antipyretic, an analgesic or an anti-inflammatory agent as an effective ingredient that can alleviate, improve or treat a cold.
본 발명의 일구체예에서, 상기 약리학적 유효성분은 아세트아미노펜, 아세틸살리실산, 페닐레프린염산염, 덱스트로메트로판브롬화수소산염수화물, 클로르페니라민말레산염, 슈도에페드린염산염, dl-메틸에페드린염산염, 덱스트로메토르판, 구아이페네신, 클로페라스틴염산염, S-이부프로펜, 브롬화수소산덱스트로메토르판, 노스카핀염산염, 트리메토퀴논염산염, 구연산카르베타펜탄, 구연산티페피딘, 페닐에페드린염산염, 페닐프로판올 아민, 덱시부프로펜, 페나세틴, 옥시메타졸린, 펜디조산클로페라스틴, d-클로르페니라민, 트리프롤리딘, 카르비녹사민, 페닐레프린 염산염 및 브롬페니라민말레산염제로 이루어진 군에서 선택된 1종 이상일 수 있다.In one specific embodiment of the present invention, the pharmacologically effective ingredient may be at least one selected from the group consisting of acetaminophen, acetylsalicylic acid, phenylephrine hydrochloride, dextromethorphan hydrobromide hydrate, chlorpheniramine maleate, pseudoephedrine hydrochloride, dl-methylephedrine hydrochloride, dextromethorphan, guaifenesin, chlorperastine hydrochloride, S-ibuprofen, dextromethorphan hydrobromide, noscapine hydrochloride, trimethoquinone hydrochloride, carbetapentane citrate, tipepidine citrate, phenylephedrine hydrochloride, phenylpropanolamine, dexibuprofen, phenacetin, oxymetazoline, chlorperastine phendizoate, d-chlorpheniramine, triprolidine, carbinoxamine, phenylephrine hydrochloride, and brompheniramine maleate.
본 발명의 제제는 상기와 같은 약리학적 유효성분 이외에 당업계에 공지된 필름형성제, 가소제, 착향제, 향미개질제, 감미제, 착색제, 현탁제, pH 조절제, 영양제, 윤활제, 보존제, 방부제, 유화제, 수화제, 계면활성제, 삼투압 조절을 위한 염 및/또는 완충제, 및 기타 치료적으로 유용한 물질을 추가로 함유할 수 있다.In addition to the pharmacologically effective ingredients described above, the formulation of the present invention may further contain film forming agents, plasticizers, flavoring agents, flavor modifiers, sweeteners, colorants, suspending agents, pH regulators, nutrients, lubricants, preservatives, antiseptics, emulsifiers, wetting agents, surfactants, salts and/or buffers for osmotic pressure control, and other therapeutically useful substances known in the art.
본 발명에서 필름형성제는 풀루란, 젤라틴, 펙틴, 저점도 펙틴, 하이드록시프로필메틸셀룰로오스, 저점도 하이드록시프로필메틸셀룰로오스, 하이드록시에틸셀룰로오스, 하이드록시프로필셀룰로오스, 카르복시메틸셀룰로오스, 폴리비닐피롤리돈, 폴리비닐알콜, 폴리아크릴산, 메틸메타크릴레이트 공중합체, 카르복시비닐 중합체, 폴리에틸렌글리콜, 알긴산, 저점도 알긴산, 알긴산 나트륨, 변성 전분, 카제인, 유장단백분리물, 콩단백분리물, 제인, 레반, 엘시난, 글루텐, 아카시아검, 카라기난, 아라비아 검, 구아 검, 로커스트빈 검, 잔탄 검, 겔란 검 및 아가로 이루어진 군으로부터 하나 이상을 선택하여 사용할 수 있다.In the present invention, the film forming agent may be selected from the group consisting of pullulan, gelatin, pectin, low viscosity pectin, hydroxypropyl methylcellulose, low viscosity hydroxypropyl methylcellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, carboxymethyl cellulose, polyvinyl pyrrolidone, polyvinyl alcohol, polyacrylic acid, methyl methacrylate copolymer, carboxyvinyl polymer, polyethylene glycol, alginic acid, low viscosity alginic acid, sodium alginate, modified starch, casein, whey protein isolate, soy protein isolate, zein, levan, elsinan, gluten, acacia gum, carrageenan, gum arabic, guar gum, locust bean gum, xanthan gum, gellan gum, and agar.
본 발명에서 가소제는 필름의 유연성을 조절할 때 사용될 수 있으며, 상기 가소제는 솔비톨, 말티톨, 자일리톨, 글리세린, 폴리에틸렌글리콜, 프로필렌글리콜, 수첨물엿, 물엿, 글리세린, 트리아세틴, 글리세롤올레이트, 자당지방산 에스테르 및 중쇄 지방산으로 이루어진 군으로부터 선택될 수 있다.In the present invention, a plasticizer can be used to control the flexibility of the film, and the plasticizer can be selected from the group consisting of sorbitol, maltitol, xylitol, glycerin, polyethylene glycol, propylene glycol, hydrogenated molasses, starch syrup, glycerin, triacetin, glycerol oleate, sucrose fatty acid ester, and medium-chain fatty acids.
본 발명에서 착향제는 식용 제품에 목적하는 향미를 부여하는 화합물 및 이들 화합물의 착화 혼합물을 포함한다. 예를 들면, 동결-건조된 천연 식물 성분, 정유(essential oil), 에센스, 추출물, 분말의 형태를 갖는 천연 및 합성 향신료(천연 향신료를 포함)이며, 맛 프로필에 영향을 줄 수 있는 산 및 기타의 물질을 포함할 수 있다. 액상 및 분말상 향신료의 예로는, 코코넛, 커피, 초콜렛, 바닐라, 포도, 오렌지, 라임, 박하, 감초, 카라멜향, 벌꿀향, 땅콩, 호두, 캐슈, 헤이즐넛, 아몬드, 파인애플, 딸기, 라스베리, 열대 과일, 체리, 계피, 페퍼민트, 동록유(wintergreen), 스피어민트, 유칼립투스, 및 민트를 포함하며, 사과, 배, 복숭아, 딸기, 살구, 라스베리, 체리, 파인애플 및 자두 에센스와 같은 과일 에센스를 포함한다. 정유로는, 페퍼민트, 스피어민트, 멘톨, 유칼립투스, 정향유, 베이유, 아나이스, 타임, 시더엽(cedar leaf)유, 너트맥, 상기한 과일 오일이 포함된다.Flavoring agents in the present invention include compounds and complexed mixtures of these compounds that impart a desired flavor to edible products. For example, natural and synthetic flavorings (including natural flavorings) in the form of freeze-dried natural plant ingredients, essential oils, essences, extracts, powders, and may include acids and other substances that can affect the taste profile. Examples of liquid and powdered flavorings include coconut, coffee, chocolate, vanilla, grape, orange, lime, peppermint, licorice, caramel, honey, peanut, walnut, cashew, hazelnut, almond, pineapple, strawberry, raspberry, tropical fruit, cherry, cinnamon, peppermint, wintergreen, spearmint, eucalyptus, and mint, and fruit essences such as apple, pear, peach, strawberry, apricot, raspberry, cherry, pineapple, and plum essences. Essential oils include peppermint, spearmint, menthol, eucalyptus, clove oil, bay oil, anais, thyme, cedar leaf oil, nutmeg, and the aforementioned fruit oils.
본 발명에서 향미개질제는 향미 화학 분야에 공지된, 다른 화합물의 맛에 대한 지각을 개질하는 화합물, 예를 들면, 쓴맛 차폐제 등을 포함한다.In the present invention, the flavor modifier includes a compound known in the field of flavor chemistry that modifies the perception of taste of other compounds, for example, a bitterness masking agent.
본 발명에서 감미제는 당류 감미제, 비-당류 감미제, 고감미 인공 감미제 등을 사용할 수 있다.In the present invention, the sweetener may be a sugar-based sweetener, a non-sugar-based sweetener, a high-sweetness artificial sweetener, etc.
상기 당류 감미제는, 단독으로 또는 조합되어 사용되는 수크로스, 덱스트로스, 말토스, 덱스트린, 트레할로스, D-타가토스, 건조 전환당, 프럭토스, 레불로스, 갈락토스, 옥수수 시럽 고형, 또는 이들의 혼합물 등을 비한정적으로 포함하는, 츄잉 검 분야에 통상적으로 알려진 사카라이드-포함 성분들을 들 수 있다.The above sugar sweeteners may include saccharide-containing ingredients commonly known in the chewing gum art, including but not limited to sucrose, dextrose, maltose, dextrin, trehalose, D-tagatose, dried invert sugar, fructose, levulose, galactose, corn syrup solids, or mixtures thereof, used alone or in combination.
상기 비-당류 감미제로는 소르비톨이 사용될 수 있다. 기타의 유용한 비-당류 감미제로는, 만니톨, 자일리톨, 수소화된 녹말 가수분해물, 말티톨, 이소말톨, 에리쓰리톨, 락티톨 등과 같은 기타의 당 알콜의 단독 또는 혼합물 형태를 포함하나 여기에 한정되는 것은 아니다.The non-sugar sweetener may be sorbitol. Other useful non-sugar sweeteners include, but are not limited to, other sugar alcohols, such as mannitol, xylitol, hydrogenated starch hydrolysate, maltitol, isomaltol, erythritol, lactitol, and the like, either singly or in mixtures.
상기 고감미 인공 감미제 또한, 단독으로, 또는 상기 감미제들과 조합하여 사용할 수 있다. 바람직한 고감미 감미제로는, 수크랄로스, 아스파탐, 아세설팜 염, 알리탐, 사카린 및 그 염, 네오탐, 시클람산 및 그 염, 글리시리진, 디히드로칼콘, 타우마틴, 모넬린, 스테리오사이드 등의 단일 화합물 또는 조합물을 포함하나, 여기에 한정되는 것은 아니다.The high-potency artificial sweeteners mentioned above can also be used alone or in combination with the above sweeteners. Preferred high-potency sweeteners include, but are not limited to, single compounds or combinations of sucralose, aspartame, acesulfame salts, alitame, saccharin and salts thereof, neotame, cyclamic acid and salts thereof, glycyrrhizin, dihydrochalcone, thaumatin, monellin, and stereosides.
본 발명의 일구체예에서, 복약순응도를 위한 단맛을 주기 위해 설탕을 쓸 수도 있지만 대체제로 감미제인 자일리톨, 아스파탐, 사카린 등을 활용하여 백당 함량을 줄이거나 없앨 수 있다. 이렇게 함으로써 아이들의 건강한 치아 건강과 식습관 유지를 도울 수 있으며, 비만 및 다른 대사질환의 위험을 줄일 수 있다. 백당을 완전히 대체하면 자기 전에 양치 없이도 투여 가능한 제형을 설계할 수도 있다.In one specific embodiment of the present invention, sugar can be used to provide sweetness for medication compliance, but the content of white sugar can be reduced or eliminated by using sweeteners such as xylitol, aspartame, and saccharin as substitutes. By doing so, it is possible to help children maintain healthy teeth and eating habits, and reduce the risk of obesity and other metabolic diseases. If white sugar is completely replaced, it is also possible to design a dosage form that can be administered before bed without brushing teeth.
또한, 본 발명은 상기와 같은 테이프형(tape-type) 또는 바형(bar type) 제제를 이용하여 길이를 통해 약물의 용량을 조절하는 방법에 관한 것이다.In addition, the present invention relates to a method for controlling the dosage of a drug through length using the tape-type or bar-type preparation as described above.
본 발명의 일구체예에서, 약리학적 유효성분으로 아세트아미노펜을 포함하는 테이프형(tape-type) 또는 바형(bar type) 제제는 길이 방향을 따라 등간격으로 할선이 형성되며, 이때, 각 구간의 간격은 1 cm마다 아세트아미노펜이 16 mg이 함유될 수 있다. 이러한 경우 하기와 같은 기준으로 길이를 통해 약물의 용량을 조절할 수 있다. In one specific example of the present invention, a tape-type or bar-type preparation containing acetaminophen as a pharmacologically active ingredient has sections formed at equal intervals along the length direction, and at this time, each section can contain 16 mg of acetaminophen at intervals of 1 cm. In this case, the dosage of the drug can be adjusted through the length based on the following criteria.
- 4-6개월: 7-7.9kg, 80mg, 5cm - 4-6 months: 7-7.9kg, 80mg, 5cm
- 7-23개월: 8-11.9kg, 120mg, 7.5cm - 7-23 months: 8-11.9kg, 120mg, 7.5cm
- 만 2세-3세: 12-15.9kg, 160mg, 10cm- 2-3 years old: 12-15.9kg, 160mg, 10cm
- 만 4세-6세: 16-22.9kg, 240mg, 15cm - 4-6 years old: 16-22.9kg, 240mg, 15cm
- 만 7세-8세: 23-29.9kg, 320mg, 20cm- 7-8 years old: 23-29.9kg, 320mg, 20cm
- 만 9세-10세: 30-37.9kg, 400mg, 25cm- 9-10 years old: 30-37.9kg, 400mg, 25cm
- 만 11세: 38-42.9kg, 480mg, 30cm- 11 years old: 38-42.9kg, 480mg, 30cm
- 만 12세 이상: 43kg 이상, 640mg, 40cm- Age 12 and over: 43kg or more, 640mg, 40cm
상기와 같은 기준은 하나의 예시일 뿐 약물의 종류, 구성성분 및 제조방법에 따라 등간격에 함유되는 약물의 용량은 달라질 수 있다. 고형(반고형) 제형의 길이를 통한 계량은 약물의 정확한 용량 투여를 가능하게 하여 효과적인 치료를 보장하고, 동시에 약물의 부작용을 최소화할 수 있다.The above criteria are only an example, and the dosage of the drug contained in equal intervals may vary depending on the type, composition, and manufacturing method of the drug. Metering through the length of a solid (semi-solid) dosage form enables accurate drug dosage administration, ensuring effective treatment, and at the same time minimizing the side effects of the drug.
이하, 실시예를 통하여 본 발명을 보다 상세히 설명하고자 한다. 이들 실시예는 본 발명을 보다 구체적으로 설명하기 위한 것으로, 본 발명의 범위가 이들 실시예에 한정되는 것은 아니다.Hereinafter, the present invention will be described in more detail through examples. These examples are intended to explain the present invention more specifically, and the scope of the present invention is not limited to these examples.
<실시예><Example>
재료ingredient
아세트아미노펜, 글리세롤, 카복시메틸셀룰로스나트륨은 Sigma-Aldrich에서 구입하였다. 이부프로펜은 Tokyo Chemical Industry에서 구입하였다. 젤라틴은 Duksan Pure Chemical에서 구입하였다. 자일리톨, 옥수수 전분, DL-사과산, 천연딸기향분말, 포도향, 레드색소RP, 퍼플그레이프칼라는 ES식품원료에서 구입하였다.Acetaminophen, glycerol, and sodium carboxymethyl cellulose were purchased from Sigma-Aldrich. Ibuprofen was purchased from Tokyo Chemical Industry. Gelatin was purchased from Duksan Pure Chemical. Xylitol, corn starch, DL-malic acid, natural strawberry flavor powder, grape flavor, red pigment RP, and purple grape color were purchased from ES Food Ingredients.
고성능 액체 크로마토그래피(HPLC) 분석 조건High Performance Liquid Chromatography (HPLC) Analysis Conditions
아세트아미노펜의 농도는 2996 포토다이오드 어레이 검출기와 2695 분리 모듈로 구성된 Waters HPLC 시스템(Milford, MA, USA)을 사용하여 분석되었다. 분석에는 Fortis C18 크로마토그래피 컬럼 (5 μm, 4.6 x 250 mm)을 사용하였고 , 컬럼 온도는 30℃로 유지하였다. 아세트아미노펜은 10μL HPLC 주입량을 사용하였다. Ph4.7/MeOH(80:20, v/v)로 구성된 이동상 은 등용매적으로 용출되었으며 유속은 1.0 mL/min이었다. 아세트아미노펜은 240nm의 파장으로 감지되었다.The concentration of acetaminophen was analyzed using a Waters HPLC system (Milford, MA, USA) consisting of a 2996 photodiode array detector and a 2695 separation module. A Fortis C18 chromatography column (5 μm, 4.6 × 250 mm) was used for the analysis, and the column temperature was maintained at 30°C. Acetaminophen was injected using a 10 μL HPLC injection volume. The mobile phase consisting of Ph4.7/MeOH (80:20, v/v) was eluted isocratically at a flow rate of 1.0 mL/min. Acetaminophen was detected at a wavelength of 240 nm.
이부프로펜의 농도는 Agilent HPLC 1260 시리즈(Agilent Technologies, USA) 사용하여 분석되었다. 분석에는 Fortis C18 크로마토그래피 컬럼 (5 μm, 4.6 x 250 mm)을 사용하였고, 컬럼 온도는 25℃로 유지하였다. 이부프로펜은 20μL HPLC 주입량을 사용하였다. MeOH/DW/Phosphoric acid(75:24.7:0.3,v/v)로 구성된 이동상은 등용매적으로 용출되었으며 유속은 1.0 mL/min이었다. 이부프로펜은 264nm의 파장으로 감지되었다.The concentration of ibuprofen was analyzed using Agilent HPLC 1260 series (Agilent Technologies, USA). A Fortis C18 chromatography column (5 μm, 4.6 x 250 mm) was used for the analysis, and the column temperature was maintained at 25℃. The HPLC injection volume for ibuprofen was 20 μL. The mobile phase consisting of MeOH/DW/Phosphoric acid (75:24.7:0.3, v/v) was eluted isocratically at a flow rate of 1.0 mL/min. Ibuprofen was detected at a wavelength of 264 nm.
<실시예 1><Example 1>
본 발명의 테이프형(tape-type) 또는 바형(bar type) 제제Tape-type or bar-type preparation of the present invention
<1-1> 젤리의 제조<1-1> Jelly production
물에 젤라틴을 풀어 약 10분간 불린 다음 100℃에서 중탕하여 완전히 녹인 후 주성분(아세트아미노펜 또는 이부프로펜), 자일리톨, DL-사과산, 글리세롤, 착향제(천연딸기향분말 또는 포도향), 식용색소(레드색소RP, 퍼플그레이프칼라)를 100℃에서 가열하여 혼합하였다. 그 후 증발한 양의 물만큼 첨가하여 전체적으로 함량이 균일한 테이프 조성물을 제조하였다. Dissolve gelatin in water, soak for about 10 minutes, then boil at 100℃ until completely dissolved. Then, mix the main ingredient (acetaminophen or ibuprofen), xylitol, DL-malic acid, glycerol, flavoring agent (natural strawberry flavor powder or grape flavor), and food coloring (red pigment RP, purple grape color) by heating at 100℃. After that, add water equivalent to the evaporated amount to produce a tape composition with uniform content overall.
상기 조성물을 형틀을 이용하여 모양을 잡는 성형과정을 4℃ 온도의 냉장고에서 24시간동안 굳혀주었다.The above composition was shaped using a mold and hardened in a refrigerator at 4°C for 24 hours.
그 후 자일리톨/옥수수 전분(95:5, w/w)을 믹서기를 통해 제조한 자일리톨 파우더를 상기 조성물과 혼합하였다.Afterwards, xylitol powder prepared by mixing xylitol/corn starch (95:5, w/w) in a mixer was mixed with the above composition.
마지막으로 젤리의 길이방향을 따라 균일한 간격으로 할선을 형성시켰다.Finally, cut lines were formed at even intervals along the length of the jelly.
본 발명의 젤리 제형의 구성성분 및 함량은 하기 표 1 및 2에 자세히 나타내었으며, 도 4에서는 실제 제조된 젤리 제형의 감기약을 보여준다.The composition and content of the jelly formulation of the present invention are shown in detail in Tables 1 and 2 below, and Fig. 4 shows a cold medicine in the jelly formulation actually manufactured.
<1-2> 구미의 제조<1-2> Manufacturing of gummies
자일리톨/옥수수 전분/카복시메틸셀룰로스나트륨 (95:5:1, w/w)을 믹서기를 통해 자일리톨 파우더를 제조하였다.Xylitol powder was prepared by mixing xylitol/corn starch/sodium carboxymethyl cellulose (95:5:1, w/w) in a mixer.
물에 젤라틴을 풀어 약 10분간 불린 다음 100℃에서 중탕하여 완전히 녹인 후 주성분(아세트아미노펜 또는 이부프로펜), DL-사과산, 글리세롤, 착향제(천연딸기향분말 또는 포도향), 식용색소(레드색소RP, 퍼플그레이프칼라)를 100℃에서 가열하여 혼합하였다. 그 후 증발한 물의 양만큼 추가하였다.Dissolve gelatin in water and soak for about 10 minutes, then boil at 100℃ until completely dissolved. Then mix the main ingredient (acetaminophen or ibuprofen), DL-malic acid, glycerol, flavoring agent (natural strawberry flavor powder or grape flavor), and food coloring (red pigment RP, purple grape color) by heating at 100℃. Then, add the same amount of water as the evaporated water.
제조한 자일리톨 파우더와 상기 조성물을 혼합하여 반죽기를 통해 반죽을 제조한 후 랩핑하여 24시간 상온에 보관하였다.The manufactured xylitol powder was mixed with the above composition, dough was made using a kneader, and then wrapped and stored at room temperature for 24 hours.
그 후 성형기를 통하여 반죽을 일정한 크기로 제조하였다.After that, the dough was made into a certain size through a molding machine.
본 발명의 구미 제형의 구성성분 및 함량은 하기 표 1 및 2에 자세히 나타내었으며, 도 5에서는 실제 제조된 구미 제형의 감기약을 보여준다.The composition and content of the gummy formulation of the present invention are shown in detail in Tables 1 and 2 below, and Fig. 5 shows a cold medicine in the gummy formulation actually manufactured.
<1-3> 제형 내 약물의 함량<1-3> Content of drug in the formulation
각 제형별 약물 함량은 아세트아미노펜은 Ph4.7/MeOH(80:20, v/v)로 구성된 용매 20ml에 각 제형의 1cm씩 취하여 60℃에서 30분 동안 혼합한 후, 용액을 0.2μm로 여과하였다. 각 제형의 아세트아미노펜 농도는 상기 설명된 HPLC를 사용하여 결정되었다.The drug content for each formulation was determined by mixing 1 cm of each formulation in 20 ml of a solvent consisting of Ph4.7/MeOH (80:20, v/v) at 60°C for 30 minutes, and then filtering the solution to 0.2 μm. The acetaminophen concentration in each formulation was determined using the HPLC described above.
각 제형별 약물 함량은 이부프로펜은 MeOH 20ml에 각 제형의 1cm씩 취하여 60℃에서 30분 동안 혼합한 후, 용액을 0.2μm로 여과하였다. 각 제형의 이부프로펜 농도는 상기 설명된 HPLC를 사용하여 결정되었다.The drug content of each formulation was determined by mixing 1 cm of each formulation in 20 ml of MeOH at 60°C for 30 minutes, and then filtering the solution to 0.2 μm. The ibuprofen concentration of each formulation was determined using the HPLC described above.
<실시예 2><Example 2>
본 발명의 테이프형(tape-type) 또는 바형(bar type) 제제를 이용한 용량 계량 방법Dosage metering method using the tape-type or bar-type preparation of the present invention
상기 <실시예 1>을 통해 준비된 제제를 이용하여 투약 대상의 몸무게와 나이에 맞춰 정확한 용량을 계량할 수 있는 기준을 제시하였다.A standard for measuring the exact dosage according to the body weight and age of the subject of administration was presented using the formulation prepared through the above <Example 1>.
상기와 같이 어린이의 몸무게와 나이에 대응하는 잘라내야 할 제형의 길이를 설정할 수 있다.As described above, the length of the formulation to be cut can be set corresponding to the child's weight and age.
이제까지 본 발명에 대하여 그 바람직한 실시예들을 중심으로 살펴보았다. 본 발명이 속하는 기술 분야에서 통상의 지식을 가진 자는 본 발명이 본 발명의 본질적인 특성에서 벗어나지 않는 범위에서 변형된 형태로 구현될 수 있음을 이해할 수 있을 것이다. 그러므로 개시된 실시예들은 한정적인 관점이 아니라 설명적인 관점에서 고려되어야 한다. 본 발명의 범위는 전술한 설명이 아니라 특허청구범위에 나타나 있으며, 그와 동등한 범위 내에 있는 모든 차이점은 본 발명에 포함된 것으로 해석되어야 할 것이다.The present invention has been described with reference to preferred embodiments thereof. Those skilled in the art will appreciate that the present invention may be implemented in modified forms without departing from the essential characteristics of the present invention. Therefore, the disclosed embodiments should be considered from an illustrative rather than a restrictive perspective. The scope of the present invention is indicated by the claims, not the foregoing description, and all differences within the scope equivalent thereto should be interpreted as being included in the present invention.
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| KR20230087724 | 2023-07-06 | ||
| KR1020240085328A KR20250007984A (en) | 2023-07-06 | 2024-06-28 | Cutable tape-type or bar type formulation with adjustable medication dose via length |
| KR10-2024-0085328 | 2024-06-28 |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20120107402A1 (en) * | 2010-10-29 | 2012-05-03 | Monosol Rx, Llc | Process for analyzing and establishing dosage size in an ingestible film |
| KR20120056824A (en) * | 2009-08-19 | 2012-06-04 | 바이엘 파마 악티엔게젤샤프트 | Drug delivery systems (wafer) for pediatric use |
| US20200315985A1 (en) * | 2001-10-12 | 2020-10-08 | Aquestive Therapeutics, Inc. | Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions |
| US20210015909A1 (en) * | 2008-09-29 | 2021-01-21 | The Corporation Of Mercer University | Oral dissolving films containing microencapsulated vaccines and methods of making same |
| US20230081553A1 (en) * | 2017-04-13 | 2023-03-16 | Nova Thin Film Pharmaceuticals Llc | Oral Soluble Film and Multi-layered Film Including an Oral Soluble Film Layer |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US20200315985A1 (en) * | 2001-10-12 | 2020-10-08 | Aquestive Therapeutics, Inc. | Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions |
| US20210015909A1 (en) * | 2008-09-29 | 2021-01-21 | The Corporation Of Mercer University | Oral dissolving films containing microencapsulated vaccines and methods of making same |
| KR20120056824A (en) * | 2009-08-19 | 2012-06-04 | 바이엘 파마 악티엔게젤샤프트 | Drug delivery systems (wafer) for pediatric use |
| US20120107402A1 (en) * | 2010-10-29 | 2012-05-03 | Monosol Rx, Llc | Process for analyzing and establishing dosage size in an ingestible film |
| US20230081553A1 (en) * | 2017-04-13 | 2023-03-16 | Nova Thin Film Pharmaceuticals Llc | Oral Soluble Film and Multi-layered Film Including an Oral Soluble Film Layer |
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