Phospholipids as anion chelating agents in pharmaceutical formulations
AssigneeR.P. Scherer Technologies, LLC
InventorsGiang Hoang Thuy Au, William Derek Bush
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Abstract
Disclosed herein are dosage forms including a fill material that incorporates an anionic chelating agent, such as lecithin, and a salt form of a basic or acidic active pharmaceutical ingredient and a free ion. The molar ratio of the anionic chelating agent, such as lecithin, to the free ion ranging from about 0.5 to about 3. Also disclosed herein are methods of stabilizing dosage forms that include a salt form of a basic or acidic active pharmaceutical ingredient, methods of preparing such dosage forms, and methods of using such dosage forms.
Claims27
A capsule comprising:
- a fill material,
- wherein the fill material comprises:
- a salt form of a basic or acidic active pharmaceutical ingredient (API) and a free anion,
- an anionic chelating agent comprising lecithin,
- wherein the molar ratio of the anionic chelating agent to the free anion ranges from about 0.5 to about 3;
- and
- a shell composition.
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A process of stabilizing a capsule comprising:
- combining a salt form of a basic or acidic active pharmaceutical ingredient (API) and a free anion with an anionic chelating agent comprising lecithin at a molar ratio of anionic chelating agent to free anion of about 0.5 to about 3 to prepare a fill material;
- and
- encapsulating the fill material in a shell composition.
A capsule comprising:
- a fill material,
- wherein the fill material comprises:
- a salt form of a basic or acidic active pharmaceutical ingredient (API) and a free anion,
- an anionic chelating agent comprising lecithin, wherein the lecithin comprises from about 10 wt % to about 95 wt % phospholipid components with positively charged functional groups, based on total weight of the lecithin;
- and
- a shell composition,
- wherein the capsule maintains its integrity at 40° C., and 3 weeks of storage, wherein the integrity of the capsule is measured based on leakage of the fill material from the shell composition.
Dependencies are inferred from the claim text.