Technology/ Title:Novel Functional Excipient for Development and Application of Insoluble Drug
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Technology Description
The synthetic polyvinyl acetate-g-methoxy polyethylene glycol polymer of functional excipients are amphilic brush polymer structure. This novel excipient is utilized as solubilizer that could increase drug solubility and enhance drug absorption. This novel excipient has better flowability, easy for use and widely application. Suitable for direct compression and granulation process that is better than HPMCAS. This excipient will be useful for new drug and insoluble drug development. Process of formulation design will be shorten and simplified.
Features:
Technical platform include synthesis and modification design of novel polymeric structure, suitability evaluation of new materials, analytical and quality control, formulation design, in vitro and in vivo study for solubility and absorption evaluation, and in vitro and in vivo test for safety and toxicity. Compared with traditional excipient, this novel excipient has better solubilizer ability and high usability, and is suitable for various dosage forms. This excipient has demonstrated its safety and without mutagenicity and repeated dose toxicity by preclinical study. Pilot scale with PIC/S GMP compliance could be manufactured and evaluated its long term stability. This novel excipient is utilized for formulation of insoluble drugs.
Intellectual Property
Patents:
Spain EP3037458
Italy EP3037458
Ireland EP3037458
France EP3037458
United Kingdom EP3037458
Germany EP3037458
United State US9,737,607
Taiwan TWI525110
China
Key Publications:
Business Opportunity
Technology Advantages:
- Enhance drug solubility, easy for operation, and widely application.
- With better safety and low toxicity.
- Suitable for formulated with various drugs.
Applications:
- BCS class II drugs, New formulation drugs, New drugs.
