Emulsions as solid dosage forms for oral administration
AssigneeCima Labs Inc.
InventorsS. Indiran Pather, Sangeeta V. Gupte, Rajendra K. Khankari, John Hontz, Ramya Kumbale
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Abstract
Novel emulsion compositions which improve the rate and/or extent of absorption of drugs are disclosed. The novel emulsion compositions of the present invention include drug-containing emulsions adsorbed onto solid particles which may be further formulated into solid dosage forms, methods of preparing such emulsion compositions and their uses thereof. The emulsion compositions and their dosage forms improve the drug-load and the bioavailability of a wide range of drugs including drugs that are known or suspected of having poor bioavailability by the utilization of several different mechanisms.
Claims38
An emulsion composition in the form of a free-flowing, compressible powder, comprising:
- an admixture of a drug-containing emulsion and a solid particle adsorbent;
- wherein said emulsion is adsorbed on said solid particle adsorbent.
An emulsion composition in the form of a free-flowing, compressible powder, comprising:
- an admixture of a drug-containing self-emulsifying drug delivery system and a solid particle adsorbent;
- wherein said drug-containing self-emulsifying drug delivery system is adsorbed onto said solid particle adsorbent and forms a free-flowing, compressible powder.
The solid dosage form of claim 29, wherein the enteric coating is selected from materials of the group consisting of a methacrylic acid copolymer, sugar, gelatin, hydroxypropyl cellulose or hydroxypropylmethyl cellulose phthalate, cellulose acetate phthalate, polyvinylacetate phthalate, methacrylic acid copolymer, shellac, hydroxypropylmethylcellulose succinate, cellulose acetate trimellitate, and their mixtures thereof.
A method for preparing an emulsion composition, comprising the steps of:
- preparing a drug-containing emulsion and converting said drug-containing emulsion into a free-flowing, compressible powder by admixing said drug-containing emulsion with a solid particle adsorbent.
A method for preparing a solid dosage form for the oral administration of a therapeutically effective amount of a drug, comprising the steps of:
- preparing a drug-containing emulsion;
- converting said drug-containing emulsion into a powder by admixing said drug-containing emulsion with a solid particle adsorbent and compressing said powder, with the optional addition of an excipient, into a solid dosage form.
A method for preparing a solid dosage form for the rectal or vaginal administration of a therapeutically effective amount of a drug, comprising the steps of:
- preparing a drug-containing emulsion;
- converting said drug-containing emulsion into a powder by admixing said drug-containing emulsion with a solid particle adsorbent and incorporating said powder into a suppository.
A method for preparing a solid dosage form for the vaginal administration of a therapeutically effective amount of a drug, comprising the steps of:
- preparing a drug-containing emulsion;
- converting said drug-containing emulsion into a powder by admixing said drug-containing emulsion with a solid particle adsorbent;
- incorporating said powder into a suppository.
A stable emulsion composition which is the product of the process of:
- preparing a drug-containing emulsion;
- converting said drug-containing emulsion into a powder by admixing said drug-containing emulsion with a solid particulate adsorbent.
Dependencies are inferred from the claim text.