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Cost Reduction in Vildagliptin Manufacturing Process

Aniruddha Shinde1

Head Manufacturing Science & Technology Group, Saurav Chemical Ltd.

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ABSTRACT

Vildagliptin is an inhibitor of the enzyme dipeptidyl peptidase 4, indicated for the treatment of type 2 diabetes mellitus, combined or not with metformin. Vildagliptin is manufactured by chemical synthesis and is also called as bulk drug manufacturing or API manufacturing. Further it is formulated as tablet for end use called as formulation.

Vildagliptin manufactured from Vildagliptin Intermediate and consists of condensation reaction with Adamantol in the presence of Potassium carbonate and solvent used in Acetone.Further it is purified with extraction and washing process and finally crystallized in 2 -Butanone. Dried and further milling, sifting and packing operations performed.

Different types of equipment used for manufacturing of Vildagliptin such as reactor for reaction, extraction , washing, distillation and crystallization, sparkler filter used for clarification, centrifuge for centrifugation of crystallized product. Dryer used for drying, Multimill used for milling and sifter used for sifting operation.

Study is performed to increase yield (output) from input by reducing loss of product during processing.

Key words: Vildagliptin, cost reduction, Process loss, purification