Biocon Limited

Mylan Gmbh

Nilanjan Sengupta

Ramakrishnan Melarkode

Harish Iyer

Anand Khedkar

Nitesh Dave

Harish Venkatraman Pai

Vivek Gopal Nayak

Shanmugam Thandava Murthy

Ranjith Ramakrishna

Sudheer Chivukula

Sundaresh Shankar

Devesh Radhakrishnan

Ramesh Subramani

Sharath Kumar Mallapura Rangappa

Anita Rao Udiavar

Vishika Hegde

Shilpa Govinda Ramaswamy

Laxmikant Vashishta

Ranjit Ravindran Pillai

Senthil Thangamuthu

Sharath Kumar Rangappa

The present disclosure relates to a process for detecting and optionally quantifying an analyte in a sample in the presence of a soluble target of the analyte. The soluble target forms a complex with the analyte and thus may interfere in determining the total analyte concentration. The process of the present invention utilizes a unique modified citrate buffer for diluting the sample containing the analyte and the soluble target which in turn helps in dissociating the analyte-soluble target complex, thereby enabling the process of the disclosure to detect and optionally quantify measure the analyte accurately.

Process for detection and optional quantification of an analyte

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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Bengaluru, India

Nilanjan Sengupta