Pharmaceutical compositions comprising coated API
AssigneeCatalent U.K. Swindon Zydis Limited
InventorsRosaleen Mclaughlin, Simon Andrew Martyn Howes, Craig Wheadon, Jonathon Whitehouse, Adam Parker, Michael John Hutchinson
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Abstract
Provided are pharmaceutical compositions and methods for preparing pharmaceutical compositions comprising coated API. Excess coating material that is not bound to coated API may be removed by a sieving process. Coating and dosing ratios can also be optimized to minimize the amount of excess unbound coating material. Additionally, the compositions can be formulated to preserve the functional coating of coated API and to minimize aeration of API when mixed into suspension.
Claims23
A pharmaceutical composition comprising:
- 60-85% w/w API;
- 10-30% w/w a water insoluble material surrounding the API to form a first coating on the API;
- 0.5-3% w/w silica surrounding the first coating of the API to form a second coating on the first coating of the API, wherein the silica produces a slower dissolution profile for the API as compared to API without silica;
- 3-7% w/w matrix former;
- and
- 2-6% w/w structure former.
A method of preparing coated API comprising:
- sieving raw API;
- mixing sieved raw API and a water insoluble material in a vessel;
- applying mechanical energy to the vessel and heating the vessel to a temperature greater than or equal to 50° C.;
- and
- adding silica to the vessel while continuing to apply the mechanical energy and maintaining the temperature of the vessel to form coated API comprising at least one coating comprising water insoluble material and silica, wherein the coated API comprises 40-85% w/w API, 10-60% w/w water insoluble material surrounding the API to form a first coating on the API, and 0.5-5% w/w silica surrounding the first coating of the API to form a second coating on the first coating of the API, wherein the silica produces a slower dissolution profile for the API as compared to API without silica.
A method of preparing a pharmaceutical composition comprising:
- forming a pharmaceutical suspension comprising:
- 30-50% w/w API comprising at least one coating, wherein the at least one coating comprises a water insoluble material and silica;
- 1-5% w/w a matrix former;
- 1-3% w/w a structure former;
- and
- a solvent;
- dosing the pharmaceutical suspension into a mold;
- and
- freeze drying the dosed pharmaceutical suspension in the mold to form the pharmaceutical composition, wherein the pharmaceutical composition comprises 60-85% w/w API, 10-30% w/w water insoluble material surrounding the API to form a first coating on the API, 0.5-3% w/w silica surrounding the first coating of the API to form a second coating on the first coating of the API, wherein the silica produces a slower dissolution profile for the API as compared to API without silica.
Dependencies are inferred from the claim text.