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US 2020/0345582 A1Published application
Methods for compounding compositions including a particle reduction step
AssigneeMedisca Pharmaceutique Inc.
InventorsPanagiota DANOPOULOS, Marc Joiner, Sarah Nyat Peng Wong, Vargha Talebi
Life of this patent
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Abstract
The present disclosure relates to a system and process for manufacturing patient personalized pharmaceutical compositions using superimposed revolution and rotation movements for dispersing, milling, melting, and/or de-aerating, where these superimposed revolution and rotation movements can be carried out in a single device in a pharmacy setting.
Claims30
A compounding method, comprising:
- in a pharmacy setting, providing a container including therein a pharmaceutically acceptable excipient, carrier or diluent, and an active pharmaceutical ingredient (API);
- subjecting the container to superimposed revolution and rotation movements to mix the pharmaceutically acceptable excipient, carrier or diluent, and the API to produce a composition exhibiting a gradient of concentration of the API with ≤6% relative standard deviation (RSD) when measured by high-performance liquid chromatography (HPLC), wherein the concentration is that of at least top, middle and bottom layers of the composition within the container.
A compounding method, comprising:
- in a pharmacy setting, providing a container including therein a pharmaceutically acceptable excipient, carrier or diluent having a first specific gravity, and an active pharmaceutical ingredient (API);
- and
- subjecting the container to superimposed revolution and rotation movements to disperse the pharmaceutically acceptable excipient, carrier or diluent, and the API and produce a composition having a second specific gravity and exhibiting a concentration gradient of the API with ≤6% relative standard deviation (RSD) when measured by high-performance liquid chromatography (HPLC), wherein the concentration is that of at least top, middle and bottom layers of the composition within the container, wherein the second specific gravity is within 50% of the first specific gravity without introducing air into the composition.
A compounding method, comprising:
- in a pharmacy setting, providing a container including therein gelatin gum base particles;
- subjecting the container to first superimposed revolution and rotation movements to disperse the particles and produce a melt composition;
- adding an active pharmaceutical ingredient (API) into the melt to obtain an API-containing melt;
- subjecting the container comprising the API-containing melt to second superimposed revolution and rotation movements to mix the API-containing melt and obtain a dispersed melt composition;
- and
- cooling the dispersed melt composition to obtain a solid composition.
3 more elements
A compounding method, comprising:
- in a pharmacy setting, providing a container including therein particles of a pharmaceutically acceptable excipient, pharmaceutically acceptable carrier, or an active pharmaceutical ingredient (API), wherein the particles have a starting D50;
- subjecting the container to first superimposed revolution and rotation movements in presence of grinding beads to produce a milled composition including particles having a milled D50, wherein the starting D50 to milled D50 represent a ratio of at least 2.5,
- removing the grinding media from the container, and
- incorporating into the milled composition at least one of a pharmaceutically acceptable excipient, pharmaceutically acceptable carrier, or API, and removing the grinding media from the container before or after said incorporating, and
- subjecting the container to second superimposed revolution and rotation movements to obtain a mixed composition.
2 more elements
Dependencies are inferred from the claim text.