Stabilization of oxygen sensitive dose forms
AssigneeAmerican Home Products Corporation
InventorStanley Sklar
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Abstract
The disclosure is directed to improvement of the stability of oxygen sensitive compounds. Phenothiazines may be stabilized by the use of small amounts of monothioglycerol in the marketable composition. Especially good results are obtained in the stabilization of promethazine formulations with monothioglycerol.
Claims10
A therapeutic composition of matter containing up to 50 milligrams per cubic centimeter of an active ingredient selected from the group consisting of promethazine and its pharmaceutically acceptable acid addition salts in a pharmaceutical carrier stabilized with at least 2 milligrams per cubic centimeter of monothioglycerol.
A therapeutic composition of matter containing 25 to 50 milligrams per cubic centimeter of an active ingredient selected from the group consisting of promethazine and its pharmaceutically acceptable acid addition salts in a pharmaceutical carrier stabilized with 2 to 5 milligrams per cubic centimeter of monothioglycerol.
An aqueous solution containing up to 50 milligrams per cubic centimeter of promethazine stabilized with at least 2 milligrams per cubic centimeter of monothioglycerol.
An oxygen-stabilized aqueous solution for use in vials and ampules containing up to 50 milligrams per cubic centimeter of an active ingredient selected from the group consisting of promethazine and its pharmaceutically acceptable acid addition salts in which the stabilizer is at least 2 milligrams per cubic centimeter of monothioglycerol.
An oxygen-stabilized aqueous solution for injection containing up to 50 milligrams per cubic centimeter of an active ingredient selected from the group consisting of promethazine and its pharmaceutically acceptable acid addition salts in which the stabilizer is at least 5 milligrams per cubic centimeter of monothioglycerol.
An aqueous solution of a promethazine salt stabilized with at least 4 percent by volume of monothioglycerol based on the volume of promethazine.
A composition having the recipe:
- ______________________________________ Promethazine hydrochloride 25-50 mg. EDTA disodium 0.099 mg. Calcium Chloride 0.039 mg. Sodium acetate 6.15 mg. Phenol 5.0 mg. Buffer to adjust to pH 5.0 Monothioglycerol 5-6 mg. Water to make 1.0 cc. ______________________________________
Dependencies are inferred from the claim text.