Biocon Limited

Sundaresh Shankar

Ramakrishnan Melarkode

Harish Iyer

Anand Khedkar

Nitesh Dave

Harish Venkatraman Pai

Nilanjan Sengupta

Devesh Radhakrishnan

Sudheer Chivukula

Ranjith Ramakrishna

Shanmugam Thandava Murthy

Sharath Kumar Mallapura Rangappa

Ramesh Subramani

Sharath Kumar Rangappa

Krishana Chaitanya Gulla

The invention relates to improvised pharmaceutical compositions permitting ingestion via oral delivery of proteins/peptides or their conjugates, and/or cation-insulin conjugate complexes demonstrating desirable pharmacokinetic profiles and potency in efficacy models of diabetes in dogs and humans. A preferred formulation comprises 0.01%-20% w/w of insulin, insulin compound conjugates and/or cation insulin conjugates, 10%-60% w/w of one or more fatty acid components selected from saturated or unsaturated C4-C12 fatty acids and/or salts of such fatty acids and additionally contains optimal amounts of other pharmaceutically suitable polymer excipients which permit improved solubility, dissolution rate and effective bioavailability of poorly water soluble compositions and consistent in-vivo release profiles upon scalability during manufacture. A further aspect of the invention features the process of preparing the aforesaid formulations.

Orally administrable solid pharmaceutical composition and a process thereof

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Karnataka, India

Sundaresh Shankar