Granted Patent
B2
US 12,201,726 · App. 17/529,827 · Granted Jan 21, 2025
Preserving functionally-coated API particles produced by solventless mixing processes in aqueous suspension
Inventors:
Rosaleen Mclaughlin (Swindon, GB); Adam Parker (Swindon, GB); Jonathon Whitehouse (Swindon, GB)
Assignee:
Catalent U.K. Swindon Zydis Limited
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Abstract
Provided are pharmaceutical compositions and methods for preparing pharmaceutical compositions that preserve the coating of coated API particles in a pharmaceutical suspension. Pharmaceutical compositions include coated active pharmaceutical ingredient (API) particles comprising: an API particle; a first coating comprising one or more deformed components coating the API particle; a second coating comprising silica surrounding and/or partially or fully embedded into the first coating, a matrix former, and a structure former.
Claims (26)
1. A pharmaceutical composition comprising:
a coated API particle comprising;
a first coating comprising a wax; and
a second coating comprising silica partially embedded in and/or embedded in the wax,
wherein the coated API particle comprises 0.5-2.5% w/w silica and the silica produces a slower dissolution profile for the API as compared to API without silica.
2. The pharmaceutical composition of claim 1 , wherein the first coating is configured to mask a taste of the API particle.
3. The pharmaceutical composition of claim 1 , comprising a matrix former comprising one or more of a water soluble material, a water dispersible material, a polypeptide, a polysaccharide, polyvinyl alcohol, polyvinylpyrrolidone, and acacia.
4. The pharmaceutical composition of claim 3 , wherein the matrix former comprises a polypeptide.
5. The pharmaceutical composition of claim 3 , wherein the matrix former comprises gelatin.
6. The pharmaceutical composition of claim 1 , comprising a structure former comprising one or more of mannitol, dextrose, lactose, galactose, and cyclodextrin.
7. The pharmaceutical composition of claim 6 , wherein the structure former comprises mannitol.
8. The pharmaceutical composition of claim 1 , wherein the wax comprises one or more of carnauba wax, candelilla wax, or synthetic wax.
9. A pharmaceutical composition comprising:
coated API particles comprising:
an API particle;
a first coating comprising a wax; and
a second coating comprising silica partially embedded in and/or embedded in the wax, wherein the coated API particle comprises 0.5-2.5% w/w silica and the silica produces a slower dissolution profile for the API as compared to API without silica,
wherein the pharmaceutical composition is prepared by mixing the coated API particles into a matrix solution/suspension to form a pharmaceutical suspension, and dosing the pharmaceutical suspension comprising the coated API particles into molds.
10. The pharmaceutical composition of claim 9 , wherein the first coating is configured to mask a taste of the API particle.
11. The pharmaceutical composition of claim 9 , comprising a matrix former comprising one or more of a water soluble material, a water dispersible material, a polypeptide, a polysaccharide, polyvinyl alcohol, polyvinylpyrrolidone, and acacia.
12. The pharmaceutical composition of claim 11 , wherein the matrix former comprises a polypeptide.
13. The pharmaceutical composition of claim 11 , wherein the matrix former comprises gelatin.
14. The pharmaceutical composition of claim 9 , comprising a structure former comprising one or more of mannitol, dextrose, lactose, galactose, and cyclodextrin.
15. The pharmaceutical composition of claim 14 , wherein the structure former comprises mannitol.
16. The pharmaceutical composition of claim 9 , wherein the dosed pharmaceutical suspension comprising the coated API particle is frozen and freeze-dried to form a freeze-dried solid dosage form.
17. The pharmaceutical composition of claim 9 , wherein the wax comprises one or more of carnauba wax, candelilla wax, or synthetic wax.
Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST
Recorded Sep 13, 2023
From: MCLAUGHLIN, ROSALEEN; PARKER, ADAM; WHITEHOUSE, JONATHON
To: CATALENT U.K. SWINDON ZYDIS LIMITED
Reel/Frame 064893/0587 →
Continuity (3)
Provisional Application
62809287
· Feb 22, 2019
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