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FORM 2 THE PATENTS ACT, 1970 (39 of 1970) & THE PATENTS RULES, 2003 COMPLETE SPECIFICATION (See section 10, rule 13) ?CONTROLLED RELEASE FORMULATIONS? GALE LTD., of Segment House, 8 Clifford Street,

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What is controlled release formulations?

Controlled release formulations are delivery systems for pharmaceuticals or chemicals that provide a slow and sustained release of the active ingredient.

Who is required to file controlled release formulations?

Manufacturers or distributors of pharmaceuticals or chemicals that utilize controlled release formulations are required to file the necessary documentation.

How to fill out controlled release formulations?

To fill out controlled release formulations, manufacturers or distributors need to provide detailed information about the formulation's composition, release mechanism, and performance.

What is the purpose of controlled release formulations?

The purpose of controlled release formulations is to optimize the delivery of active substances, ensuring a steady and prolonged release over a specified period, enhancing therapeutic efficacy and reducing potential side effects.

What information must be reported on controlled release formulations?

Information that must be reported on controlled release formulations includes the composition and proportions of all ingredients, release kinetics, stability data, and any relevant safety or efficacy studies.

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