Stabilization of solid thyroid drug formulations
AssigneeMutual Pharmaceutical Company, Inc.
InventorSpiridon Spireas
Life of this patent
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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 thyroid drugs 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.
Claims28
A stable drug dosage form prepared be compression techniques comprising:
- a thyroid hormone susceptible to moisture induced degradations, and
- particles of at least one pharmaceutically acceptable excipient, each particle having an exterior surface, an interior, equilibrium moisture disposed within the interior of the particles, the thyroid hormone being in contact with the exterior surface of the particles of the at least one pharmaceutically acceptable excipient;
- the dosage form prepared by:
- admixing the thyroid hormone and the at least one pharmaceutically acceptable excipient;
- and
- compacting the thyroid hormone and the at least one pharmaceutically acceptable excipient into unit dosage forms using compression pressures of less than about 5000 psi/g;
- wherein the compression pressure limits the amount of equilibrium moisture available to react with the thyroid hormone at the exterior surface of the particles of the at least one pharmaceutically acceptable excipient.
A stable drug dosage form comprising:
- a hydrophobic solid powder;
- a thyroid hormone susceptible to moisture induced degradation, treated with said hydrophobic solid powder to substantially water-proof said thyroid hormone;
- and
- at least one pharmaceutically acceptable excipient.
A method for administering a thyroid hormone to a patient comprising:
- providing a unit dose comprising:
- a hydrophobic solid powder;
- a thyroid hormone susceptible to moisture induced degradation, treated with said hydrophobic solid powder to substantially waterproof said thyroid hormone;
- and
- at least one pharmaceutically acceptable excipient;
- said stable dosage form prepared by:
- admixing said thyroid hormone with said hydrophobic powder, each particle of thyroid hormone being substantially enveloped by said hydrophobic powder,
- adding said at least one pharmaceutically acceptable excipient to said admixture of said thyroid hormone and said hydrophobic powder;
- compacting said enveloped thyroid hormone, said at least one pharmaceutically acceptable excipient, and said hydrophobic powder using a compression pressure of less than 5000 psi/g.
A method for preparing a stable drug dosage form comprising:
- a hydrophobic solid powder;
- a thyroid hormone susceptible to moisture induced degradation, treated with said hydrophobic solid powder to substantially water-proof said thyroid hormone;
- and
- at least one pharmaceutically acceptable excipient;
- the method comprising the steps of:
- admixing said thyroid hormone with said hydrophobic powder, each particle of thyroid hormone being substantially enveloped by said hydrophobic powder,
- adding said at least one pharmaceutically acceptable excipient to said admixture of said thyroid hormone and said hydrophobic powder;
- compacting said enveloped thyroid hormone, said at least one pharmaceutically acceptable excipient, and said hydrophobic powder using a compression pressure of less than 5000 psi/g.
Dependencies are inferred from the claim text.