Granted Patent
B2
US 12,350,372 · App. 18/451,593 · Granted Jul 8, 2025
Minimizing agglomeration of drug particle coating material during storage to stabilize disintegration times of pharmaceutical products
Inventors:
Rosaleen McLaughlin (Swindon, GB); Simon Andrew Martyn Howes (Swindon, GB); Craig Wheadon (Swindon, GB); Jonathon Whitehouse (Herne Bay, GB)
Assignee:
Catalent U.K. Swindon Zydis Limited
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Abstract
Provided are pharmaceutical compositions and methods for preparing pharmaceutical compositions using solventless mixing methods. Excess coating material that is not bound to a coated API particle may be removed by a sieving process. Coating and dosing ratios can also be optimized to minimize the amount of excess unbound coating material. Specifically, a coating ratio and/or a dosing ratio can be used to minimize the residual amount of excess unbound coating material to minimize agglomeration of coating material during storage. In some embodiments, a pharmaceutical composition is provided, the pharmaceutical composition comprising: 65-85% w/w API particles; 15-30% w/w coating material coating the API particles; and 3-15% w/w matrix surrounding the coated API particles, wherein the pharmaceutical composition comprises a disintegration time rate of less than 10 seconds for at least six months under storage conditions of at least 25° C. and at least 60% relative humidity.
Claims (18)
1. A pharmaceutical composition comprising:
65-85% w/w API particles;
15-30% w/w coating material encapsulating the API particles, wherein the coating material comprises wax and silica and the coated API particles comprise 0.5-5 wt. % silica; and
3-15% w/w matrix surrounding the coated API particles, wherein the pharmaceutical composition comprises a disintegration time of less than 10 seconds for at least six months under storage conditions of at least 25° C. and at least 60% relative humidity.
2. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises a disintegration time of less than 10 seconds for at least six months under storage conditions of at least 30° C. and at least 65% relative humidity.
3. The pharmaceutical composition of claim 1 , wherein the pharmaceutical composition comprises a disintegration time of less than 10 seconds for at least six months under storage conditions of at least 40° C. and at least 75% relative humidity.
4. The pharmaceutical composition of claim 1 , wherein the API particles comprise one or more of anti-inflammatories, analgesics, anti-psychotics, anti-emetics, laxatives, anti-diarrheals, anti-histamines, or anti-depressants.
5. The pharmaceutical composition of claim 1 , wherein the wax comprises one or more of carnauba wax, candelilla wax, or synthetic wax.
6. The pharmaceutical composition of claim 1 , wherein a coating ratio used to combine the API particles with the coating material comprises 5-85% w/w coating material and 15-95% w/w uncoated API particles.
7. The pharmaceutical composition of claim 1 , wherein the matrix comprises a matrix former and a structure former.
8. The pharmaceutical composition of claim 7 , wherein the matrix former comprises one or more of a water soluble material, a water dispersible material, a polypeptide, a polysaccharide, polyvinyl alcohol, polyvinylpyrrolidone, and acacia.
9. The pharmaceutical composition of claim 7 , wherein the matrix former comprises a polypeptide.
10. The pharmaceutical composition of claim 8 , wherein the polypeptide comprises gelatin.
11. The pharmaceutical composition of claim 6 , wherein the structure former comprises one or more of mannitol, dextrose, lactose, galactose, and cyclodextrin.
12. The pharmaceutical composition of claim 6 , wherein the structure former comprises mannitol.
13. The pharmaceutical composition of claim 1 , wherein the silica produces a slower dissolution profile for the API as compared to API without silica.
14. The pharmaceutical composition of claim 13 , wherein the coated API particles comprise 0.5-2.5 wt. % silica.
15. The pharmaceutical composition of claim 14 , wherein the silica is partially embedded in and/or embedded in the wax.
Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Sep 15, 2023
From: MCLAUGHLIN, ROSALEEN; HOWES, SIMON ANDREW MARTYN; WHEADON, CRAIG; WHITEHOUSE, JONATHON
To: CATALENT U.K. SWINDON ZYDIS LIMITED
Reel/Frame 064924/0680 →
Continuity (5)
Provisional Application
62809307
· Feb 22, 2019
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