Stable Compositions comprising Linaclotide
AssigneeAurobindo Pharma Ltd
InventorsShridhar Inaganti, Venugopala Chokkasandra Jayarama Reddy, Jayant Karajgi, Sivakumaran Meenakshisunderam
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Abstract
The present invention relates to stable oral composition comprising linaclotide or its pharmaceutically acceptable salts, complexes, polymorphs, hydrates, solvates, enantiomers or racemates, process of preparation thereof and methods of using the same.
Claims31
A stable oral composition comprising linaclotide and at least one cation in an amount from about 0.5% to 5% by weight of the composition, wherein the said composition is substantially free of a primary amine.
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A process for preparation of stable oral composition of linaclotide comprising:
- i) loading inert cores in fluid bed processor;
- ii) preparing an aqueous solution comprising a cation, hydrochloric acid, hydroxypropylmethyl cellulose and linaclotide;
- iii) layering the inert cores of step (i) with the drug solution of step (ii) to form drug layered pellets;
- iv) optionally seal coating the drug layered pellets using a dispersion comprising at least one polymer optionally along with one or more excipients;
- v) lubricating the pellets;
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- vi) encapsulating the lubricated pellets in to capsules of suitable size.
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Dependencies are inferred from the claim text.