Stabilization of solid drug formulations
First Claim
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1. A drug dosage form prepared by compression techniques comprising:
- a substantially non-volatile, pharmaceutically acceptable oil, anda compound susceptible to moisture-induced degradation treated with the substantially non-volatile, pharmaceutically acceptable oil to substantially waterproof the compound susceptible to moisture-induced degradation;
the drug dosage form prepared by;
(a) dispersing the compound susceptible to moisture-induced degradation in the substantially non-volatile, pharmaceutically acceptable oil; and
(b) compacting the compound susceptible to moisture-induced degradation into dosage forms using compression pressures of up to 5,000 psi/g.
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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 formulations toward moisture-induced degradation. Hydrophobic powders are also optionally added to the formulations.
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Citations
28 Claims
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1. A drug dosage form prepared by compression techniques comprising:
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a substantially non-volatile, pharmaceutically acceptable oil, and a compound susceptible to moisture-induced degradation treated with the substantially non-volatile, pharmaceutically acceptable oil to substantially waterproof the compound susceptible to moisture-induced degradation; the drug dosage form prepared by; (a) dispersing the compound susceptible to moisture-induced degradation in the substantially non-volatile, pharmaceutically acceptable oil; and (b) compacting the compound susceptible to moisture-induced degradation into dosage forms using compression pressures of up to 5,000 psi/g. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10)
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11. A drug dosage form prepared by compression techniques comprising:
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a pharmaceutically acceptable excipient admixed with a substantially non-volatile pharmaceutically acceptable oil; and a compound susceptible to moisture-induced degradation treated with the pharmaceutically acceptable excipient to substantially waterproof the compound susceptible to moisture-induced degradation; wherein the drug dosage form is prepared by; (a) dispersing the compound susceptible to moisture-induced degradation in the pharmaceutically acceptable excipient; (b) compacting the compound susceptible to moisture-induced degradation into dosage forms using compression pressures of up to 5,000 psi/g. - View Dependent Claims (12, 13, 14, 15, 16)
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17. A drug form prepared by compression techniques comprising:
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a compound susceptible to moisture-induced degradation treated with a first pharmaceutically acceptable oil to substantially waterproof the compound susceptible to moisture-induced degradation; and a pharmaceutically acceptable excipient admixed with a second pharmaceutically acceptable oil to substantially waterproof the pharmaceutically acceptable excipient, wherein the first pharmaceutical acceptable oil is different from the second pharmaceutically acceptable oil; the drug dosage form prepared by; (a) dispersing the compound susceptible to moisture-induced degradation in the pharmaceutically acceptable excipient; (b) compacting the compound susceptible to moisture-induced degradation into dosage forms using compression pressures of up to 5,000 psi/g. - View Dependent Claims (18, 19, 20, 21, 22)
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23. 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.
- 24. 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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27. 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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28. 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