Wafer and capsule formulations with enhanced dissolution rates for fenofibrate
AssigneeLTS Lohmann Therapie-Systeme AG
InventorsMichael Li, Markus Krumme
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Abstract
The invention relates to developing a novel water and capsule formulation using fenofibrate which is difficult to dissolve and control its release rate in vitro. For example, the invention relates to the creation of capsules and wafers comprising: fenofibrate, a surfactant, a carrier wax, a film former, a plasticizer, and optionally a super disintegrant or other ingredients. The invention further relates to the process of forming such capsules and wafers.
Claims3
A process of making a wafer with a dosage of a BCS class II compound which comprises:
- (a) forming a hot melt by heating together the BCS class II compound with an emulsifier and a carrier wax material;
- (b) homogenizing the hot melt and adding the hot melt to an aqueous solution to form an oil-in-water (O/W) emulsion comprising microparticles of the BCS class II compound;
- (c) cooling the O/W emulsion followed by adding a film forming polymer, and optionally a super disintegrant, to the cooled O/W emulsion to form a liquid mass;
- (d) drying the liquid mass to form a film;
- and
- (e) cutting the film to form the wafer;
- wherein the BCS class II compound consists essentially of fenofibrate.
A process of making a capsule with a dosage of a BCS class II compound which comprises:
- (a) forming a hot melt by heating together the BCS class II compound with an emulsifier and a carrier wax material;
- (b) homogenizing the hot melt and adding the hot melt to an aqueous solution to form an oil-in-water (O/W) emulsion comprising microparticles of the BCS class II compound;
- (c) cooling the O/W emulsion followed by adding a film forming polymer, and optionally a super disintegrant, to the cooled O/W emulsion to form a liquid mass;
- (d) drying the liquid mass to form a film;
- (e) cutting the film to form a wafer;
- (f) forming fine particles from the wafer;
- (g) mixing the fine particles with a super disintegrant to form a particle mixture;
- and
- (h) loading the particle mixture into a capsule;
- wherein the BCS class II compound consists essentially of fenofibrate.
Dependencies are inferred from the claim text.