Invention Grant
- Patent Title: Stable pilocarpine formulations with modified buffer characteristics and related methods
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Application No.: US18154524Application Date: 2023-01-13
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Publication No.: US11857538B2Publication Date: 2024-01-02
- Inventor: Mandar V. Shah , Veerappan Subramanian , Ilango Subramanian , Aman Trehan
- Applicant: Somerset Therapeutics, LLC
- Applicant Address: US FL Hollywood
- Assignee: Somerset Therapeutics, LLC
- Current Assignee: Somerset Therapeutics, LLC
- Current Assignee Address: US FL Hollywood
- Agency: Transformative Legal LLC
- Agent Len S. Smith; Denise M. Brown
- Main IPC: A61K31/4178
- IPC: A61K31/4178 ; A61K9/08 ; A61K9/00 ; A61K47/18 ; A61K47/36 ; A61K47/26 ; A61K9/06 ; A61K47/12

Abstract:
Disclosed herein, are, among other things, stable, pharmaceutically acceptable and ophthalmologically suitable reduced buffer content and reduced buffering capacity pilocarpine compound compositions. In aspects, such compositions comprise therapeutically effective amounts of a pilocarpine compound, an effective amount of a uniform buffer component, wherein the concentrations of pilocarpine compound and uniform buffer component are limited to specific relative amounts and wherein the uniform buffer component is defined by one or more markedly distinguishing characteristics from buffers used in developed pilocarpine products (e.g., a unique pKa and/or concentration). Aspects of the invention include compositions defined by unique concentrations of such and other ingredients. Such compositions surprisingly exhibit pharmaceutically acceptable stability and, in aspects, stability equal to or statistically significantly greater than that of one or more on-market/developed reference product(s). Further, the invention provides methods of manufacturing such and similar compositions, and methods of their use in treating ocular conditions such as presbyopia.
Public/Granted literature
- US20230263775A1 STABLE PILOCARPINE FORMULATIONS WITH MODIFIED BUFFER CHARACTERISTICS AND RELATED METHODS Public/Granted day:2023-08-24
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