KR20160043565A - A Pharmaceutical Composition comprising Montelukast and Antihistamine - Google Patents
A Pharmaceutical Composition comprising Montelukast and Antihistamine Download PDFInfo
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- A61K31/00—Medicinal preparations containing organic active ingredients
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Abstract
본 발명은 몬테루카스트 및 항히스타민 함유 복합제 의약조성물에 관한 것이다. 본 발명에 따른 의약 조성물은 특정 종류의 용출조절제를 적정범위로 투입시켜 두 성분을 함께 제제화 함으로써, 각각 두 성분 모두 정상적인 용출이 되도록 개선하고, 궁극적으로는 목표 치료효과에 필요한 혈중 약물농도에 도달하게 하여 두 성분의 상승적 약리효과를 충분히 달성하게 할 수 있을 뿐만 아니라, 제조상의 생산공정의 어려움 개선과 수율 향상을 통한 생산원가도 함께 개선한 복합제 의약 조성물에 관한 것이다. The present invention relates to a pharmaceutical composition comprising a montelukast and an antihistamine. The medicinal composition according to the present invention can be prepared by injecting a specific kind of elution control agent into an appropriate range and formulating the two components together so that the two components are both eluted to a normal elution state and ultimately reach the blood drug concentration necessary for the desired therapeutic effect Which is capable of sufficiently achieving synergistic pharmacological effects of the two components, and improving the production cost by improving the difficulty of the production process in the production process and improving the yield.
Description
본 발명은 몬테루카스트 및 항히스타민 함유 복합제 의약조성물에 관한 것으로, 보다 구체적으로 설명하면 본 발명은 특정 종류의 용출조절제를 적정범위로 투입시켜 두 성분을 함께 제제화 함으로써, 각각 두 성분 모두 정상적인 용출이 되도록 개선하고, 궁극적으로는 목표 치료효과에 필요한 혈중 약물농도에 도달하게 하여 두 성분의 상승적 약리효과를 충분히 달성할 수 있을 뿐만 아니라, 제조상 생산공정의 어려움 개선과 수율향상을 통한 생산원가도 함께 개선한 복합제 의약 조성물에 관한 것이다.
The present invention relates to a pharmaceutical composition containing a montelukast and an antihistamine. Specifically, the present invention relates to a pharmaceutical composition comprising montelukast and an antihistamine, wherein the two components are formulated together by injecting a certain kind of elution control agent in an appropriate range, , Ultimately reaching the blood drug concentration necessary for the desired therapeutic effect, not only can the synergistic pharmacological effect of the two components be sufficiently attained, but also the production cost is improved by improving the difficulty of the manufacturing process and improving the yield, ≪ / RTI >
일반적으로, 천식(Asthma)은 초기 대부분 흡입제 형태의 베타-2 항진제나 스테로이드제를 투여하여 기관지 확장을 통해 기도 폐색을 예방 또는 치료하며, 추가적으로 경구제 형태의 류코트리엔 길항제를 기관지 염증억제를 위한 보조요법으로 사용하기도 한다. In general, asthma is initially administered in the form of an inhalant, a beta-2 agonist or a steroid, to prevent or treat airway obstruction through bronchial dilation. In addition, an oral form of leukotriene antagonist may be used as adjunct therapy for bronchial inflammation inhibition .
그러나, 1차 치료제로 사용되는 스테로이드 제제의 경우, 장기 사용시 내성 발생은 물론 어린이 성장부진이나 골밀도 저하, 면역 결핍 등의 부작용이 발생할 우려가 있다. 또한 베타-2 항진제는 신속한 효과를 발현하기는 하지만, 역시 내성 발생으로 인해 응급시 치료효과가 떨어지게 되는 문제점이 있다. 그리고 이러한 흡입제들은 모두 인체 내 세기관지까지 약물 전달이 어려워 약효가 충분히 발휘되지 못하는 한계가 있어 이들의 장기적 사용이나 과다한 사용은 바람직하지 않아왔다. However, in the case of a steroid preparation used as a first-line treatment, side effects such as poor growth of children, lowering of bone density, and immunodeficiency may occur as well as resistance to long-term use. In addition, although the beta-2 agonist exhibits a rapid effect, there is also a problem that the therapeutic effect is reduced when an emergency occurs due to resistance generation. In addition, these inhalants have a limitation in that they can not be sufficiently administered because of difficulties in delivering drugs to the human body, and long-term use or overuse of these inhalants has been undesirable.
따라서, 상기 흡입제들의 다양한 문제점과 과다한 약물 사용으로 인한 부작용을 개선하기 위한 보조요법으로 기관지 염증 억제용 경구제인 류코트리엔 길항제를 병용해 왔다. 그러나, 이들 류코트리엔 길항제만으로는 기관지 염증 개선효과가 충분하지 않아 단독요법으로는 여전히 약효가 부족한 문제점이 있어 왔으며, 이에 대한 보완이 필요한 실정이었다. Thus, leukotriene antagonists, bronchial inflammation-suppressing agents, have been used as adjunctive therapies to improve various problems of the inhalants and side effects due to excessive drug use. However, these leukotriene antagonists alone have not been effective in improving the bronchial inflammation, so that there is still a problem in that the efficacy of the monotherapy is still insufficient.
이러한 요구에 따라 국제공개특허 WO1999/32125호는 류코트리엔 길항제와 항히스타민제를 유효성분으로 하는 의약 조성물이 기관지 천식에 대한 상승적 치료효과가 있을 것으로 예상하고 있음을 개시하고 있다. 그러나, 상기 특허에는 류코트리엔 길항제와 항히스타민제 가운데 몬테루카스트 등의 류코트리엔 길항제와 에피나스틴, 아젤라스틴과 같은 항히스타민을 함께 제제화 하는 경우 두 성분간에 발생될 수 있는 물리화학적 상호작용 등 용출에 영향을 미치는 다양한 제제상의 여러 문제점에 대해서는 구체적인 언급이 전혀 없을 뿐만 아니라, 본 발명에서와 같이 단순혼합의 경우 발생될 수 있는 응집으로 인해 용출이 저하된다는 사실은 전혀 인식조차 못하고 있었다. 더구나, 상기 특허에는 복합제 제제화 경우 사용가능한 다양한 붕해제[예: 스타치, 카르복시메틸스타치나트륨과 같은 변형 스타치, 천연 및 합성 검, 메틸셀룰로오스 및 카르복시메틸셀룰로오스와 같은 셀룰로오스류, 크로스카멜로스나트륨 같은 미결정셀룰로오스 및 크로스-링크 미결정셀룰로오스류, 알긴산류, 벤토나이트와 같은 클레이 등]도 개시하고 있는데, 이들 붕해제들 각각이 용출에 미치는 효과가 전혀 개시되어 있지 않음은 물론, 복합제내 두성분의 용출을 동시에 개선하는 데에 한계가 있는 것으로 확인되었다. In accordance with this demand, WO999 / 32125 discloses that a pharmaceutical composition containing an leukotriene antagonist and an antihistamine agent as an active ingredient is expected to have a synergistic therapeutic effect on bronchial asthma. However, the above patent discloses that when leukotriene antagonists such as montelukast and antihistamine such as epinastine and azelastine are formulated together with leukotriene antagonist and antihistamine agent, various preparations which influence dissolution such as physicochemical interactions that may occur between the two components There is no specific reference to the problems of the present invention, and it is not recognized at all that the elution is reduced due to aggregation which may occur in simple mixing as in the present invention. In addition, the above patent discloses a variety of disintegrants that can be used in the case of combination formulation, such as starch, modified starches such as sodium carboxymethylstarch, natural and synthetic gums, celluloses such as methylcellulose and carboxymethylcellulose, croscarmellose sodium Such as microcrystalline cellulose and cross-linked microcrystalline cellulose, alginic acid, and clay such as bentonite, etc. These effects are not disclosed at all on the effect of each of these disintegrants, It is confirmed that there is a limit to improvement at the same time.
따라서, 본 발명의 발명자들은 이러한 문제점을 인식하고 문제점을 해결하고자 노력하여 이미 지난 2012년 6월, 두 성분간의 상호작용을 최소화하기 위하여 상호 분리하여 배치하는 분리상 관련 특허를 출원한 바 있다[대한민국 특허출원 제 2012-69220호]. 그러나, 이러한 연구에도 불구하고 상기 분리상을 통한 제제는 특수 제조설비인 다층정 타정기를 사용하여야 하며, 사용함에 있어서도 제조상 생산공정의 복잡성에 따른 어려움이나 생산수율이 현저히 떨어지게 되어 생산원가가 높아지는 등의 문제점이 있어 추가적인 연구의 필요성이 절실히 요구되던 실정이었다.Accordingly, the inventors of the present invention have recognized such a problem and tried to solve the problem, and in June, 2012, they filed a separation-related patent for separating the two components in order to minimize the interaction between the two components [ Patent Application No. 2012-69220]. Despite these studies, however, the preparation through the separation phase requires the use of a multi-layer tablet machine, which is a special manufacturing facility, and it is difficult to use the production process even when the production process is complicated, And the need for further research was urgently needed.
Montelukast Epinastine Montelukast Epinastine
이에, 본 발명이 해결하고자 하는 과제는 몬테루카스트와 항히스타민제 두 성분을 함께 복합제로 제제화 하는 경우, 이들 제제내에 특정 종류의 용출조절제를 적정범위로 투입하여 두 유효성분의 정상적인 용출에 가장 바람직한 조건을 확인함으로써, 두 유효성분의 용출이 정상적으로 되도록 개선하여 목표 치료효과에 필요한 혈중 약물농도에 도달하게 하여 두 성분의 상승적 약리효과를 충분히 달성할 수 있게 하고, 또한 생산공정의 복잡성에 따른 제조상의 어려움과 생산수율의 향상을 통한 생산원가도 동시에 개선한 복합제 의약 조성물을 제공하는 데에 있다.
Accordingly, a problem to be solved by the present invention is to provide a combination of montelukast and antihistamine together with a specific type of elution control agent in the form of a combination, and determine the most favorable conditions for the normal elution of the two active ingredients Thus, the dissolution of the two active ingredients is improved so that the concentration of the drug in the blood required for the desired therapeutic effect can be reached. Thus, the synergistic pharmacological effect of the two components can be sufficiently achieved, And to provide a combined pharmaceutical composition which simultaneously improves the production cost by improving the yield.
본 발명은 몬테루카스트 및 항히스타민 함유 복합제 의약조성물에 관한 것이다.The present invention relates to a pharmaceutical composition comprising a montelukast and an antihistamine.
우선, 본 발명에 따른 의약조성물은 크로스포비돈, 카르복시메틸셀룰로오스칼슘, 소듐스타치글리콜레이트 중에서 선택된 1종 이상의 용출조절제를 포함하는 몬테루카스트 및 항히스타민 함유 복합제이다. 통상 용출조절제로는 붕해제를 포함하여 붕해 촉진효과를 나타내는 결합제 등을 사용할 수 있으나, 본 발명은 크로스포비돈, 카르복시메틸셀룰로오스칼슘 또는 소듐스타치글리콜레이트 가운데 1종 이상 포함하는 것을 특징으로 한다. 특히 크로스포비돈의 경우 주성분 1중량부 대비 0.01 내지 10 중량부의 함량을 포함하거나, 0.03 내지 7 중량부, 또는 0.1 내지 3 중량부의 함량을 포함하는 것이 바람직하다. 또한, 카르복시메틸셀룰로오스칼슘은 주성분 1중량부 대비 0.01 내지 10 중량부로 포함하거나, 0.03 내지 7 중량부, 그리고 0.1 내지 3 중량부를 포함하는 것이 바람직하다. 그리고, 마지막으로 소듐스타치글리콜레이트는 주성분 1중량부 대비 0.01 내지 10 중량부로 포함하거나, 0.03 내지 7 중량부, 그리고 0.1 내지 3 중량부를 포함하는 것이 바람직하다. 또한, 상기 용출조절제의 함량은 전체 조성물 함량의 0.1 내지 50 중량%, 보다 바람직하게는 0.5 내지 30 중량%, 가장 바람직하게는 1 내지 20 중량%이며, 이들 함량은 전체 의약품 함량에 따라 통상적인 범위내에서 조절이 가능하다. 왜냐하면, 이들 성분이 너무 과량 함유되거나 너무 소량 함유되는 경우 두 성분 모두의 용출이 바람직해지지 않기 때문이다. First, the pharmaceutical composition according to the present invention is a combination of montelukast and antihistamine, which comprises at least one elution regulator selected from crospovidone, carboxymethylcellulose calcium and sodium starch glycolate. As a usual release controlling agent, a binder capable of promoting disintegration including a disintegrant can be used, but the present invention is characterized in that it comprises at least one of crospovidone, carboxymethylcellulose calcium or sodium starch glycolate. In particular, in the case of crospovidone, it preferably contains the content of 0.01 to 10 parts by weight, or 0.03 to 7 parts by weight, or 0.1 to 3 parts by weight based on 1 part by weight of the main component. Also, it is preferable that the carboxymethyl cellulose calcium is contained in an amount of 0.01 to 10 parts by weight, or 0.03 to 7 parts by weight, and 0.1 to 3 parts by weight based on 1 part by weight of the main component. Finally, it is preferable that sodium starch glycolate is contained in an amount of 0.01 to 10 parts by weight, or 0.03 to 7 parts by weight, and 0.1 to 3 parts by weight based on 1 part by weight of the main component. In addition, the content of the elution regulator is 0.1 to 50% by weight, more preferably 0.5 to 30% by weight, and most preferably 1 to 20% by weight, based on the total composition, It is possible to control within. This is because, if these components are contained in too much or too small amounts, elution of both components is not preferable.
이러한 본 발명의 유효성분인 몬테루카스트는 1일 1 ∼ 2회 복용량으로서 4 ∼ 20mg이 바람직하고, 4 ∼ 10mg이 더욱 바람직하다. 또한 에피나스틴은 1일 1 ∼ 2회 복용량으로서 5 ∼ 40mg이 바람직하며, 특히 5 ∼ 20mg이 더욱 바람직하다. 그리고, 아젤라스틴의 경우 0.5 ∼ 2mg이 바람직하며, 특히 1 ∼ 1.4mg이 더욱 바람직하다.The montelukast, which is the active ingredient of the present invention, is preferably 4 to 20 mg, more preferably 4 to 10 mg, in a dose of 1 to 2 times per day. In addition, epinastine is preferably used in an amount of 1 to 2 times a day, preferably 5 to 40 mg, more preferably 5 to 20 mg. In the case of azelastine, it is preferably 0.5 to 2 mg, more preferably 1 to 1.4 mg.
이상에서와 같은 본 발명의 복합제는 두 주성분들이 혼합된 형태의 정제, 캡슐제, 필름제 등의 경구제형이 바람직하며, 통상의 제조방법으로 제조가능하다.
The complex of the present invention as described above is preferably an oral formulation such as tablets, capsules, film, etc. in which the two main components are mixed, and can be manufactured by a conventional manufacturing method.
본 발명은 몬테루카스트 및 항히스타민 함유 복합제 의약조성물에 관한 것으로, 본 발명에 따른 의약 조성물은 각각 두 성분 모두 정상적인 용출이 되도록 개선하고, 궁극적으로는 목표 치료효과에 필요한 혈중 약물농도에 도달하게 하여 두 성분의 상승적 약리효과를 충분히 달성할 수 있을 뿐만 아니라, 제조상의 어려움과 생산원가도 함께 개선할 수 있는 효과가 있다.
The present invention relates to a pharmaceutical composition containing a montelukast and an antihistamine, wherein the medicinal composition according to the present invention improves both of the two components so as to be a normal elution and ultimately reaches a blood drug concentration necessary for a desired therapeutic effect, Not only the synergistic pharmacological effect can be sufficiently achieved, but also the manufacturing difficulty and the production cost can be improved.
도 1은 용출개시 후 30분 경과시점에서 각 비교예 및 실시예의 몬테루카스트 용출율을 비교한 그래프이다. 도 2는 용출개시 후 30분 경과시점에서 각 비교예 및 실시예의 에피나스틴 용출율을 비교한 그래프이다.
FIG. 1 is a graph comparing the dissolution rates of montelukast in each of Comparative Examples and Examples at the elapsed time of 30 minutes from the start of dissolution. FIG. 2 is a graph comparing the dissolution rates of epinastine in each of Comparative Examples and Examples at the elapsed time of 30 minutes from the start of elution.
이하, 본 발명의 이해를 돕기 위하여 바람직한 실시예 및 실험예를 제시한다. 그러나, 하기의 실시예 및 실험예는 본 발명을 보다 쉽게 이해하기 위하여 제공되는 것일 뿐, 이들 실시예 및 실험예에 의해 본 발명의 권리범위가 제한되는 것은 아니다.
Hereinafter, preferred embodiments and experimental examples are provided to facilitate understanding of the present invention. However, the following examples and experimental examples are provided only for the purpose of easier understanding of the present invention, and the scope of the present invention is not limited by these examples and experimental examples.
실시예Example
1 ∼ 1 ~
실시예Example
2 및 2 and
비교예Comparative Example
1 ∼ 5 1-5
하기 표 1에 나타낸 성분과 함량을 가지고 통상의 방법으로 충분히 균일하게 혼합한 뒤 타정기를 이용하여 타정하였다. The ingredients and the contents shown in Table 1 were mixed in a substantially uniform manner by a conventional method, followed by tableting using a tablet machine.
실험예Experimental Example
실시예 및 비교예에서 제조된 정제에 대해 용출시험을 진행하였다. 용출시험은 제조된 정제 각 1정을 가지고 용출액으로 정제수 900mL, 패들법, 회전속도 50rpm으로 진행하였다. 용출시험 개시 후 30분에 약 5mL를 채취한 후 멤브레인필터로 여과한 후 3mL을 버리고 1mL를 취하여 고속액체크로마토그래프법에 따라 시험하였다. 고속액체크로마토그래프법에 따라 에피나스틴염산염 및 몬테루카스트나트륨은 순차대로 분리되어 나오며, 각 피크의 면적값을 적분하여 농도로 산출하였으며, 그 결과는 표 2 및 표 3과 도 1 및 도 2에 각각 나타내었다. 이때, 각 성분의 용출율(%)은 정제내의 몬테루카스트나트륨 및 에피나스틴 각각이 모두 용출액에 녹았을 때의 농도를 100%로 할 때 채취한 시점에서 산출된 몬테루카스트나트륨 및 에피나스틴의 농도를 백분율로 나타내었다. 이와 별도로 몬테루카스트나트륨을 함유한 시판의약품인 싱귤레어정 및 에피나스틴염산염을 함유한 시판의약품인 알레지온정의 용출시험을 진행하였으며, 그 결과 두 성분 모두 30분 기준 몬테루카스트 70% 이상, 에피나스틴 85% 이상으로 바람직한 용출기준을 확인하였다. The tablets prepared in Examples and Comparative Examples were subjected to a dissolution test. The elution test was carried out with 900 mL of purified water, paddle method, and a rotation speed of 50 rpm as an eluent with one tablet each of the prepared tablets. Approximately 5 mL was taken 30 minutes after the initiation of the dissolution test, followed by filtration through a membrane filter. 3 mL was discarded and 1 mL was taken and tested according to a high-performance liquid chromatography method. The epinastine hydrochloride and montelukast sodium were sequentially separated according to the high performance liquid chromatography method and the area values of the respective peaks were integrated to calculate the concentration. The results are shown in Tables 2 and 3 and FIGS. 1 and 2 Respectively. When the concentration of montelukast sodium and epinastine in the eluate is 100%, the percentage of montelukast sodium and epinastine calculated at the time of collection is expressed as a percentage Respectively. Separately, a dissolution test was carried out on a commercially available drug containing both montelukast sodium-containing drugs Sincare and Epinastine hydrochloride. As a result, both of the ingredients were montelukast 70% or more, epinastine 85% Thus, preferred elution criteria were confirmed.
Claims (6)
Wherein the composition comprises at least one elution regulator selected from the group consisting of crospovidone, carboxymethylcellulose calcium, and sodium starch glycolate.
The pharmaceutical composition according to claim 1, wherein the content of the elution regulator is 0.1 to 50% by weight of the total medicinal composition.
The pharmaceutical composition according to claim 1, wherein the crospovidone content is 0.01 to 10 parts by weight based on 1 part by weight of the main ingredient.
The pharmaceutical composition according to claim 1, wherein the carboxymethylcellulose calcium is 0.01 to 10 parts by weight based on 1 part by weight of the main ingredient.
The pharmaceutical composition according to claim 1, wherein the sodium starch glycolate is contained in an amount of 0.01 to 10 parts by weight based on 1 part by weight of the main ingredient.
The pharmaceutical composition according to any one of claims 1 to 5, wherein the antihistamine is selected from epinastine or azelastine.
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