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WO2024186829A2 - Comprimé orodispersible et procédés de fabrication associés - Google Patents

Comprimé orodispersible et procédés de fabrication associés Download PDF

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Publication number
WO2024186829A2
WO2024186829A2 PCT/US2024/018544 US2024018544W WO2024186829A2 WO 2024186829 A2 WO2024186829 A2 WO 2024186829A2 US 2024018544 W US2024018544 W US 2024018544W WO 2024186829 A2 WO2024186829 A2 WO 2024186829A2
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WO
WIPO (PCT)
Prior art keywords
tableting composition
liquid
orally
active pharmaceutical
disintegrating tablet
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
PCT/US2024/018544
Other languages
English (en)
Other versions
WO2024186829A3 (fr
Inventor
Ricardo Arturo ANDRADE HUITRÓN
Kristin LANDGREN
Trevor Williams
Leyu ZHANG
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bayer Healthcare LLC
Original Assignee
Bayer Healthcare LLC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Bayer Healthcare LLC filed Critical Bayer Healthcare LLC
Publication of WO2024186829A2 publication Critical patent/WO2024186829A2/fr
Publication of WO2024186829A3 publication Critical patent/WO2024186829A3/fr
Anticipated expiration legal-status Critical
Pending legal-status Critical Current

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Classifications

    • 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
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2009—Inorganic compounds
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2004—Excipients; Inactive ingredients
    • A61K9/2022—Organic macromolecular compounds
    • A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
    • A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
    • 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
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing

Definitions

  • the present disclosure generally relates to orally disintegrating tablets, and more specifically, to orally disintegrating tablets that are produced by introducing air prior to drying.
  • ODTs Orally disintegrating tablets
  • ODTs are tablets that dissolve or disintegrate in a patient’s oral cavity in thirty seconds or less.
  • ODTs are not designed to be swallowed whole.
  • ODTs are a particularly attractive dosage form for patients who have trouble swallowing or are a non- compliance risk.
  • ODTs can also be administered without water, and often provide faster relief than swallowable tablets or capsules.
  • Lyophilization or freeze drying, is a process by which water is removed after the product is frozen and placed under a vacuum. This process is typically used to preserve perishable materials, extend shelf life, or increase transportability. It can also reduce drying times by 30%.
  • the process of lyophilization forms a porous, light tablet that dissolves quickly in a patient’s oral cavity to efficiently deliver the active pharmaceutical ingredient of the tablet to the patient.
  • ODTs orally disintegrating tablets
  • the process further introduces air into a liquid tableting composition to form a foam.
  • the foam is then dosed and dried to form an ODT.
  • ODTs and ODTs prepared using a method that includes introducing air into a liquid tableting composition to form a foam that is then dosed and dried.
  • the ODTs described herein can be produced using less total ingredients, can be vegan, can be lighter, and can be prepared on conventional and more accessible equipment.
  • the ODTs described herein may be formed without a binder and/or a superdisintegrant.
  • conventional ODTs are prepared using a binder and a superdisintegrant. Therefore, the ODTs described herein include a more straightforward and simplistic ingredient list.
  • an orally-disintegrating tablet prepared from a liquid tableting composition comprising: 25-50 wt. % sugar; 0.25-2 wt. % hydroxypropyl methylcellulose; 0.1-1 wt. % xanthan gum; 1-30 wt. % active pharmaceutical ingredient; and 45- 75 wt. % water.
  • the active pharmaceutical ingredient comprises loratadine or a pharmaceutically acceptable salt thereof.
  • the sugar comprises one or more of sucrose, compressible sugar, or a sugar alcohol.
  • the orally-disintegrating tablet does not include a superdisintegrant.
  • the orally-disintegrating tablet does not include a binder.
  • the orally-disintegrating tablet does not comprise any animal-derived products.
  • the orally-disintegrating tablet does not comprise gelatin.
  • the orally-disintegrating tablet is lighter in weight than a compressed tablet.
  • the orally-disintegrating tablet has a weight of about 75 mg/dose.
  • the orally-disintegrating tablet comprises less total number of ingredients than an orally-disintegrating tablet prepared using lyophilization.
  • a method for preparing an orally-disintegrating tablet comprising: forming an active pharmaceutical ingredient suspension comprising water, one or more active pharmaceutical ingredients, and a first amount of hydroxypropyl methylcellulose; forming a dry blend comprising sugar, a second amount of hydroxypropyl methylcellulose, and xanthan gum; mixing the dry blend and the active pharmaceutical ingredient suspension to form a liquid tableting composition; aerating the liquid tableting composition to form a foam tableting composition; dosing the foam tableting composition to form a dosed tableting composition; and drying the dosed tableting composition to form orally-disintegrating tablets.
  • forming a dry blend comprising sugar, a second amount of hydroxypropyl methylcellulose, and xanthan gum comprises a first amount of sugar.
  • the first amount of sugar comprises half of a total amount of sugar.
  • the method comprises adding a second amount of sugar to the combined dry blend and active pharmaceutical ingredient suspension.
  • the first amount of hydroxypropyl methylcellulose comprises 0.25 mg hydroxypropyl methylcellulose for every 100 g water.
  • mixing the dry blend and the active pharmaceutical ingredient suspension to form a liquid tableting composition comprises mixing with a whisk to introduce air into the composition comprising the dry blend and the active pharmaceutical ingredient suspension.
  • dosing the liquid tableting composition comprises piping the blend into a desired shape.
  • dosing the liquid tableting composition comprises dosing into molds.
  • drying the dosed tableting composition comprises drying the dosed tableting composition at 3O-5O°C for 1-3 hours.
  • mixing the dry blend and the active pharmaceutical ingredient suspension to form a liquid tableting composition and aerating the liquid tableting composition to form a foam tableting composition occur simultaneously.
  • aerating the liquid tableting composition to form a foam tableting composition occurs subsequently to mixing the dry blend and the active pharmaceutical ingredient suspension to form a liquid tableting composition.
  • mixing the dry blend and the active pharmaceutical ingredient suspension to form a liquid tableting composition comprises mixing the dry blend while simultaneously adding the active pharmaceutical ingredient suspension to the dry blend to form a liquid tableting composition.
  • mixing the dry blend and the active pharmaceutical ingredient suspension to form a liquid tableting composition comprises mixing the active pharmaceutical ingredient suspension while simultaneously adding the dry blend to the active pharmaceutical ingredient suspension to form a liquid tableting composition.
  • an orally-disintegrating tablet prepared using the method of: forming an active pharmaceutical ingredient suspension comprising water, one or more active pharmaceutical ingredients, and a first amount of hydroxypropyl methylcellulose; forming a dry blend comprising sugar, a second amount of hydroxypropyl methylcellulose, and xanthan gum; mixing the dry blend and the active pharmaceutical ingredient suspension to form a liquid tableting composition; aerating the liquid tableting composition to form a foam tableting composition; dosing the foam tableting composition to form a dosed tableting composition; and drying the dosed tableting composition to form orally-disintegrating tablets.
  • mixing the dry blend and the active pharmaceutical ingredient suspension to form a liquid tableting composition and aerating the liquid tableting composition to form a foam tableting composition occur simultaneously.
  • aerating the liquid tableting composition to form a foam tableting composition occurs subsequently to mixing the dry blend and the active pharmaceutical ingredient suspension to form a liquid tableting composition.
  • mixing the dry blend and the active pharmaceutical ingredient suspension to form a liquid tableting composition comprises mixing the dry blend while simultaneously adding the active pharmaceutical ingredient suspension to the dry blend to form a liquid tableting composition.
  • mixing the dry blend and the active pharmaceutical ingredient suspension to form a liquid tableting composition comprises mixing the active pharmaceutical ingredient suspension while simultaneously adding the dry blend to the active pharmaceutical ingredient suspension to form a liquid tableting composition.
  • a method for treating allergies comprising administering an orally disintegrating tablet according to any of the oral disintegrating tablet embodiments above, to a human in need thereof, wherein the active pharmaceutical ingredient is loratadine or a pharmaceutically acceptable salt thereof.
  • any one or more of the features, characteristics, or elements discussed above with respect to any of the embodiments may be incorporated into any of the other embodiments mentioned above or described elsewhere herein.
  • FIG. 1 shows a process of preparing an orally -disintegrating tablet, according to some embodiments.
  • ODTs orally disintegrating tablets prepared using common manufacturing equipment.
  • the process used to prepare the ODTs described herein introduces air into a liquid tableting composition to form a foam.
  • the foam is then dosed and dried to form an ODT.
  • ODTs and ODTs prepared using a method that includes introducing air into a liquid tablet base to form a foam that is then dosed and dried.
  • ODTs prepared using the methods described herein also include fewer ingredients than an ODT prepared using lyophilization, are vegan (e.g., do not contain gelatin), and are lighter than an ODT prepared using lyophilization.
  • ODTs prepared using a foam tableting composition, followed by methods of preparing the ODTs.
  • ODTs liquid tableting compositions Described below are ODTs liquid tableting compositions.
  • orally disintegrating tablets are defined as tablets that dissolve or disintegrate within thirty seconds or less in a subject’s oral cavity.
  • liquid tableting composition refers to a pre-dried composition comprising all liquid and solid ingredients.
  • a “foam tableting composition” refers to a tableting composition includes the addition of air to form a foam.
  • the foam tableting composition is formed by adding air to a liquid tableting composition.
  • a “dosed tableting composition” is a tableting composition that has been dosed into a mold, for example.
  • the dosed tableting composition is the foam tableting composition that has been dosed.
  • each of the “liquid tableting composition,” the “foam tableting composition,” and the “dosed tableting composition” can be the same.
  • the liquid tableting composition is formed once all ingredients have been combined.
  • the only difference between the liquid tableting composition and the foam tableting composition is the introduction of air (to form a foam).
  • the only difference between the dosed tableting composition and the liquid tableting composition is the addition of air (to form a foam) and the placement (dosing).
  • the ODTs described herein are vegan, include fewer ingredients than an ODT prepared using lyophilization, and are lighter in weight than an ODT prepared using lyophilization.
  • ODTs may comprise one or more active pharmaceutical ingredients (APIs).
  • suitable APIs can include an antihistamine such as loratadine, desloratadine, diphenhydramine, cetirizine, fexofenadine, or pharmaceutically acceptable salts thereof, a non-steroidal anti-inflammatory drug such as ibuprofen or meloxicam or pharmaceutically acceptable salts thereof, an analgesic such as paracetamol or a pharmaceutically acceptable salt thereof, and/or a diuretic such as pamabrom or caffeine or pharmaceutically acceptable salts thereof.
  • an ODT may be prepared from a liquid tableting composition comprising 1-30, 1-20, or 1-10 wt.
  • an ODT may be from a liquid tableting composition comprising less than or equal to 30, 25, 20, 15, 10, or 5 wt. % API. In some embodiments, an ODT may be formed from a liquid tableting composition comprising greater than or equal to 1, 5, 10, 15, 20, or 25 wt. % API.
  • the ODTs described herein are vegan.
  • Most ODTs, for example, those prepared using lyophilization, include gelatin to help form a matrix that holds the other ingredients together.
  • gelatin is formed from decaying animal hides, boiled crushed bones, and the connective tissues of cattle and pigs, and thus, is animal-derived.
  • the ODTs described herein are formed using a vegan foaming agent.
  • Suitable vegan foaming agents include hydroxypropyl methylcellulose (HPMC) or aquafaba powder instead of gelatin.
  • HPMC hydroxypropyl methylcellulose
  • Aquafaba powder is a natural extract of chickpea, and contains a combination of starches, proteins, and saponins that allows it to foam a mixture well.
  • HPMC or aquafaba powder instead of gelatin, the ODTs described herein have no dependency on animals for their production, and can appeal to more people (e.g., those who are vegan or otherwise wish to avoid animal-derived products).
  • ODTs described herein may be prepared from a liquid tableting composition comprising 0.1-10, 0.1-5, or 1-5 wt. % foaming agent. In some embodiments, ODTs described herein may be prepared from a liquid tableting composition comprising less than or equal to 10, 9, 8, 7, 6, 5, 4, 3, 2, 1, or 0.5 wt. % foaming agent. In some embodiments, ODTs described herein may be prepared from a liquid tableting composition comprising greater than or equal to 0.1, 0.5, 1, 2, 3, 4, 5, 6, 7, 8, or 9 wt. % foaming agent.
  • Sugar can be used in ODTs to sweeten the product.
  • Suitable sugars can include, but are not limited to, compressible sugar, sucrose, or sugar alcohol.
  • ODTs described herein may be prepared from a liquid tableting composition comprising 20-60, 30-40, or 35-45 wt. % sugar.
  • ODTs described herein may be prepared from a liquid tableting composition comprising less than or equal to 60, 55, 50, 45, 40, 35, 30, or 25 wt. % sugar.
  • ODTs described herein may be prepared from a liquid tableting composition comprising greater than or equal to 20, 25, 30, 35, 40, 45, 50, or 55 wt. % sugar.
  • Stabilizers may be used in ODTs described herein as a thickener and/or to stabilize the liquid tableting composition and/or product. Suitable stabilizers can include one or more of xanthan gum, guar gum, or gellan gum.
  • ODTs described herein may be prepared from a liquid tableting composition comprising 0.001-1, 0.01-1, 0.01-0.5, or 0.01-0.1 wt. % stabilizer.
  • ODTs described herein may be prepared from a liquid tableting composition comprising less than or equal to 1, 0.5, 0.1, .05, 0.01, or 0.005 wt. % stablizer.
  • ODTs described herein may be prepared from a liquid tableting composition comprising greater than or equal to 0.001, 0.005, 0.01, 0.05, 0.1, or 0.5 wt. % stabilizer.
  • Flavoring agents may be used in ODTS according to some embodiments described herein to improve the palatability of the product.
  • flavoring agents can be used to mask unpleasant (e.g., bitter) flavored APIs.
  • Suitable flavoring agents can include, but are not limited to, mango flavor, orange flavor, strawberry flavor, cherry flavor, mint flavor, lemon flavor, lime flavor, grape flavor, mixed berry flavor, or raspberry flavor.
  • ODTs described herein may be prepared from a liquid tableting composition comprising 0.1-5 or 0.1-2 wt. % flavoring agent.
  • ODTs described herein may be prepared from a liquid tableting composition comprising less than or equal to 5, 4, 3, 2, 1, or 0.5 wt. % flavoring agent.
  • ODTs described herein may be prepared from a liquid tableting composition comprising greater than or equal to 0.1, 0.5, 1, 2, 3, or 4 wt. % flavoring agent.
  • a flavoring agent may include citric acid. Citric acid can be used as both a flavoring agent and for pH modulation.
  • a liquid tableting composition may have a pH of 4.5-5. In some embodiments, a liquid tableting composition may have a pH of 4.8.
  • ODTs described herein include water to help form a matrix with the HPMC to stabilize the liquid tableting composition and final product.
  • ODTs described herein may be prepared from a liquid tableting composition comprising 30-70, 40-60, or 45-55 wt. % water.
  • ODTs described herein may be prepared from a liquid tableting composition comprising less than or equal to 70, 65, 60, 55, 50, 45, 40, or 35 wt. % water.
  • ODTs described herein may be prepared from a liquid tableting composition comprising greater than or equal to 30, 35, 40, 45, 50, 55, 60, or 65 wt. % water.
  • a stabilized liquid composition refers to physical stability, e.g., it does not precipitate or lose its foamy lift too quickly (in the case of an aerated foam tableting composition).
  • Table 1 shows an example liquid tableting composition that can be used to form ODTs using the methods described herein.
  • the ODTs described herein include fewer ingredients.
  • the ODTs prepared using methods described herein do not include a superdisintegrant.
  • a superdisintegrant is not necessary because the air added to the liquid tableting composition increases the surface area of solids in the tablet that can be exposed to solvent (e.g., water, saliva).
  • solvent e.g., water, saliva
  • superdisintegrants increase the surface area of tablet exposed to water by wicking the water through the tablet.
  • solvent flows through the gas bubbles even faster than that of a conventional orally-disintegrating tablet with a superdisintegrant(s).
  • Common superdisintegrants include croscarmellose, crospovidone, sodium starch glycolate, and magnesium aluminum silicate, and they encourage the rapid breakdown of the ODT when in a patient’s oral cavity.
  • the ODTs prepared using methods described herein do not include a binder.
  • a binder is not necessary because the process for forming the ODTs do not include tablet compression, like conventional ODT forming processes. In fact, the inclusion of a binder in the formulations described herein may actually be detrimental to the formation of the foam ODTs.
  • Common binders can include acacia, copovidone, carbomer, carboxymethylcellulose sodium, dextrin, guar gum, maltodextrin, starch, povidone, and sorbitol.
  • the dry weight or dry mass of an ODT prepared using the methods described herein is also less than that of a compressed tablet.
  • a compressed tablet may have a mass that is double or triple that of a foam ODT prepared using the methods described herein.
  • an ODT prepared according to methods prepared herein can be 50-150, 50-100, or 70- 80 mg per dose. In some embodiments, an ODT prepared using methods provided herein may be less than or equal to 150, 140, 130, 120, 110, 100, 90, 80, 70, or 60 mg per dose. In some embodiments, ODTs prepared using the methods described herein may be greater than or equal to 50, 60, 70, 80, 90, 100, 110, 120, 130, or 140 mg per dose. In some embodiments, an ODT prepared using the methods described herein may be about 75 mg per dose. A lighter dosage form, such as the ODTs prepared using methods described herein, can reduce storage and transportation costs.
  • Table 1 below shows a liquid tableting composition that can be used to make an ODT using the methods described herein, according to some embodiments.
  • the ODTs according to embodiments provided herein do not include lyophilization, or freeze-drying. Instead, the ODTs described herein are manufactured using conventional drug manufacturing equipment, unlike that of lyophilization processes, which requires specialized and complex equipment. Additionally, the processes described in further detail below include preparing a liquid tableting composition, introducing air into the liquid tableting composition to aerate the composition to generate a foam, forming a foam tableting composition, and dosing and drying the foam tableting composition to form ODTs. This process is described in further detail below.
  • FIG. 1 shows a process 100 for manufacturing ODTs according to some embodiments described herein.
  • an active pharmaceutical ingredient (API) suspension is formed.
  • forming an API suspension can include combining water and the one or more APIs in a mixer. High-shear mixing or an homogenizer may be used to suspend the API.
  • a first amount of hydroxypropyl methylcellulose (HPMC) may be added to stabilize the suspension, if necessary.
  • HPMC hydroxypropyl methylcellulose
  • a first amount of HPMC may include 0.25 g HPMC for every 100g of water.
  • a dry blend is prepared by mixing dry ingredients.
  • the dry blend can include one or more of a first amount of the sugar, a second amount of HPMC, citric acid, flavoring agent(s), or xanthan gum.
  • a first amount of sugar may include half of the total amount of sugar.
  • a second amount of HPMC may include the remaining HPMC (minus the first portion of HPMC).
  • the dry blend may be mixed with a whisk.
  • the dry blend may be mixed at a speed of 1000-10,000 or 3000-5000 rpm.
  • the dry blend may be mixed at a speed of less than or equal to 10,000, 8000, 6000, 4000, or 2000 rpm.
  • the dry blend may be mixed at a speed of greater than or equal to 1000, 2000, 4000, 6000, or 8000 rpm.
  • the API suspension is combined with the dry blend. This can be accomplished simultaneously while the dry blend is being mixed, as described immediately above.
  • the API suspension may be added to the dry blend when the dry blend is not actively being mixed, and then the API and dry blend may be mixed together thereafter.
  • the dry blend may be added to the API suspension while the API suspension is being mixed together. The order in which the dry blend is added during mixing of the API suspension or the API suspension is added to during mixing of the dry blend can depend on the particular foaming agent that is used.
  • the API suspension and dry blend should be mixed until the dry blend is dissolved into the API suspension to form a liquid tableting composition.
  • the liquid tableting composition can be mixed at high speed.
  • this mixing step can introduce air into the liquid tableting composition sufficient to cause the tableting composition to foam and form a foam tableting composition.
  • the liquid tableting composition may be mixed at about 200 rpm for 5 to 10 minutes, or until stiff peaks are formed (e.g., until the foam mixture is formed by the mixing process). At this step, any remaining sugar may be added while the liquid tableting composition is being mixed.
  • liquid tableting composition may be mixed together, and then the liquid tableting composition may be foamed in a subsequent step.
  • mechanical methods can include stirring, stamping, squeezing, or introducing gas with a washer.
  • air can be introduced by way of phase transition of a propellant such as nitrous oxide.
  • the liquid tableting composition may be mixed together, and then the liquid tableting composition may be foamed in a subsequent step.
  • the amount of air introduced into the liquid tableting composition is from 1 to 9 times the volume of the liquid tableting solution. In some embodiments, the amount of air introduced into the liquid tableting composition is less than or equal to 9, 8, 7, 6, 5, 4, 3, or 2 times the volume of the liquid tableting solution. In some embodiments, the amount of air introduced into the liquid tableting composition is greater than 1, 2, 3, 4, 5, 6, 7, or 8 times the volume of the liquid tableting solution. Introducing air into the liquid tableting composition forms a foam tableting composition.
  • the foam tableting composition may be dosed.
  • the foam tableting composition may be piped into a desired ODT shape.
  • the foam tableting composition may be dosed into molds.
  • each dose comprises approximately 150 mg tableting composition, or dosed tableting composition.
  • the dosed tableting composition is allowed to dry.
  • the dosed tableting composition may dry at room temperature.
  • the dosed tableting composition may dry in an oven at 30-100 or 30-50°C.
  • the dosed tableting composition may dry in an oven at less than or equal to 100, 80, 60, or 40°C.
  • the dosed tableting composition may dry in an oven at greater than or equal to 30, 40, 60, or 80°C.
  • the dosed tableting composition may dry in 10 minutes to 10 hours or 1-3 hours.
  • the dosed tableting composition may dry in less than or equal to 10, 8, 6, 4, 2, 1, or 0.5 hours.
  • the dosed tableting composition may dry in greater than or equal to 10 minutes, 0.5, 1, 2, 4, 6, or 8 hours.
  • kits for treating one or more health conditions comprising administering an orally-disintegrating tablet (ODT) described herein.
  • ODT orally-disintegrating tablet
  • methods for treating allergies e.g., hay fever, hives, conjunctivitis and reactions to insect bites or stings
  • the method comprising administering to a patient an ODT comprising loratadine or a pharmaceutically-acceptable salt thereof.
  • methods for treating allergies e.g., hay fever, hives, conjunctivitis and reactions to insect bites or stings
  • the method comprising administering to a patient an ODT comprising desloratidine or a pharmaceutically-acceptable salt thereof.
  • methods for treating allergies (e.g., hay fever, hives, conjunctivitis and reactions to insect bites or stings), the method comprising administering to a patient an ODT comprising diphenhydramine or a pharmaceutically-acceptable salt thereof.
  • allergies e.g., hay fever, hives, conjunctivitis and reactions to insect bites or stings
  • methods for treating allergies (e.g., hay fever, hives, conjunctivitis and reactions to insect bites or stings), the method comprising administering to a patient an ODT comprising cetirizine or a pharmaceutically-acceptable salt thereof.
  • allergies e.g., hay fever, hives, conjunctivitis and reactions to insect bites or stings
  • methods for treating allergies (e.g., hay fever, hives, conjunctivitis and reactions to insect bites or stings), the method comprising administering to a patient an ODT comprising fexofenadine or a pharmaceutically-acceptable salt thereof.
  • allergies e.g., hay fever, hives, conjunctivitis and reactions to insect bites or stings
  • methods for treating pain, reducing fever, and/or decreasing inflammation, the method comprising administering to a patient an ODT comprising ibuprofen or a pharmaceutically-acceptable salt thereof.
  • methods for treating pain, reducing fever, and/or decreasing inflammation, the method comprising administering to a patient an ODT comprising meloxicam or a pharmaceutically-acceptable salt thereof.
  • methods for treating pain, the method comprising administering to a patient an ODT comprising paracetamol or a pharmaceutically-acceptable salt thereof.
  • methods for promoting diuresis, the method comprising administering to a patient an ODT comprising pamabrom or a pharmaceutically- acceptable salt thereof.
  • methods for promoting diuresis, the method comprising administering to a patient an ODT comprising caffeine or a pharmaceutically- acceptable salt thereof.

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Abstract

Sont prévus des comprimés orodispersibles (ODT) et des procédés de fabrication d'ODT qui comprennent l'introduction d'air dans une composition de compression liquide pour former une composition de compression sous forme de mousse, le dosage de la composition de compression sous forme de mousse pour former une composition de compression dosée, et le séchage de la composition de compression dosée pour former les ODT.
PCT/US2024/018544 2023-03-07 2024-03-05 Comprimé orodispersible et procédés de fabrication associés Pending WO2024186829A2 (fr)

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US63/450,447 2023-03-07

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WO2024186829A3 WO2024186829A3 (fr) 2024-10-24

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CA2969013C (fr) * 2015-06-30 2020-04-07 Daiichi Sankyo Company, Limited Composition pharmaceutique offrant des proprietes de prevention de l'abus
US11096895B2 (en) * 2018-05-17 2021-08-24 Fertin Pharma A/S Oral tablet suitable for active pharmaceutical ingredients
US11058633B2 (en) * 2018-05-17 2021-07-13 Fertin Pharma A/S Disintegrating oral tablet suitable for active pharmaceutical ingredients
WO2020115709A1 (fr) * 2018-12-06 2020-06-11 Flamel Ireland Limited Composition pharmaceutique à libération modifiée
US10925853B2 (en) * 2019-04-17 2021-02-23 Nordiccan A/S Oral cannabinoid tablet

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