Preserving functionally-coated API particles produced by solventless mixing processes in aqueous suspension
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.
1. A pharmaceutical composition comprising:
a coated API particle comprising;
a first coating comprising one or more deformed components coating the API particle, wherein the one or more deformed components comprises 15-30 wt. % one or more of carnauba wax, candelilla wax, or synthetic wax; and
a second coating comprising hydrophobic fumed silica on top of the first coating, wherein the coated API particle comprises 0.5-10 wt. % hydrophobic fumed silica,
a matrix former; and
a structure former.
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 , 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.
4. The pharmaceutical composition of claim 1 , wherein the matrix former comprises a polypeptide.
5. The pharmaceutical composition of claim 1 , wherein the matrix former comprises gelatin.
6. The pharmaceutical composition of claim 1 , wherein the structure former comprises one or more of mannitol, dextrose, lactose, galactose, and cyclodextrin.
7. The pharmaceutical composition of claim 1 , wherein the structure former comprises mannitol.
8. A pharmaceutical composition comprising:
coated API particles comprising:
an API particle;
a first coating comprising one or more deformed components, wherein the one or more deformed components comprises 15-30 wt. % one or more of carnauba wax, candelilla wax, or synthetic wax; and
a second coating comprising hydrophobic fumed silica, wherein the coated API particles comprise 0.5-10 wt. % hydrophobic fumed silica;
a matrix former; and
a structure former,
wherein the pharmaceutical composition is prepared by mixing the coated API particles into a matrix solution/suspension comprising the matrix former and the structure former and a solvent to form a pharmaceutical suspension, and dosing the pharmaceutical suspension comprising the coated API particles into molds.
9. The pharmaceutical composition of claim 8 , wherein the first coating is configured to mask a taste of the API particle.
10. The pharmaceutical composition of claim 8 , 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.
11. The pharmaceutical composition of claim 8 , wherein the matrix former comprises a polypeptide.
12. The pharmaceutical composition of claim 8 , wherein the matrix former comprises gelatin.
13. The pharmaceutical composition of claim 8 , wherein the structure former comprises one or more of mannitol, dextrose, lactose, galactose, and cyclodextrin.
14. The pharmaceutical composition of claim 8 , wherein the structure former comprises mannitol.
15. The pharmaceutical composition of claim 8 , wherein the dosed pharmaceutical suspension comprising the coated API particle is frozen and freeze-dried to form a freeze-dried solid dosage form.