Stabilization of solid drug formulations
First Claim
1. A drug dosage form comprising a compound susceptible to moisture-induced degradation and at least one pharmaceutically acceptable excipient prepared under conditions of low compression.
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Accused Products
Abstract
Pharmaceutical formulations and dosage forms are provided having improved stability to moisture-induced degradation when compared with conventional dosage forms, especially tablets. The invention features low compression forms of drugs known to be susceptible to moisture-induced degradation together with excipients, preferably in encapsulated forms. In other embodiments, relatively non-volatile oils can be admixed with the drug and/or the excipients to stabilize the formulation toward moisture-induced degradation. Hydrophobic powders are also optionally added to the formulations.
26 Citations
42 Claims
- 1. A drug dosage form comprising a compound susceptible to moisture-induced degradation and at least one pharmaceutically acceptable excipient prepared under conditions of low compression.
- 12. A drug dosage form for a compound susceptible to moisture-induced degradation comprising the compound admixed with a substantially non-volatile, pharmaceutically acceptable oil.
- 22. A drug dosage form for a compound susceptible to moisture-induced degradation comprising the drug and a pharmaceutically acceptable excipient admixed with a substantially non-volatile, pharmaceutically acceptable oil.
- 28. A drug dosage form comprising a compound susceptible to moisture-induced degradation admixed with a first pharmaceutically acceptable oil together with a pharmaceutically acceptable excipient admixed with a second pharmaceutically acceptable oil.
- 34. A drug dosage form comprising a compound susceptible to moisture-induced degradation and at least one pharmaceutically acceptable hydrophobic powder.
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37. A method for administering a compound susceptible to moisture-induced degradation to a patient comprising providing a unit dose of the compound which has not been processed employing high compression.
- 38. A method for administering a compound susceptible to moisture-induced degradation to a patient comprising providing a unit dose of the compound admixed with a substantially non-volatile, pharmaceutically acceptable oil.
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41. A method for administering a compound susceptible to moisture-induced degradation to a patient comprising providing a unit dose of the compound and a pharmaceutically acceptable excipient admixed with a substantially non-volatile, pharmaceutically acceptable oil.
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42. A method for administering a compound susceptible to moisture-induced degradation to a patient comprising providing a unit dose of the compound and at least one pharmaceutically acceptable hydrophobic powder.
Specification