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Published on:March 2019
Indian Journal of Pharmaceutical Education and Research, 2019; 53(2s):xx-xx
Original Article | doi:10.5530/ijper.53.2.x

Screening of Silk Fibroin as a Stabilizer for Freeze Drying of Thermolabile Drug


Authors and affiliation (s):

Pooja Mirajkar, Ashok Hajare*

Department of Pharmaceutics, Bharati Vidyapeeth College of Pharmacy, Kolhapur-416013, Maharashtra, INDIA.

Abstract:

Stability issue of heat sensitive pharmaceuticals is a major problem which can be solved by number of methods and one amongst them is use of natural material Silk fibroin. In the present research work an attempt is made to investigate use of silk fibroin as a stabilizer for model thermolabile drug Tenofovir Alafinamide Fumarate (TAF). Different formulations based on literature reviewed and trials were prepared by using silk fibroin as a stabilizer and were processed by lyophilization. Using various features such % drug content, % moisture retention and appearance of lyophilize and investigation by modern techniques such FT-IR, XRD, DSC formulations were tested to confirm suitability of silk fibroin. Initially for achieving desirable product features the fibroin concentration was optimized. The optimized concentration of fibroin was compared with commonly used cryoprotectants mannitol and sucrose. The efficiency of fibroin as cryoprotectant was compared using product features. It was observed that product features and stabilization efficiency of fibroin was lower than mannitol where as it was better than sucrose. The short term stability study with respect to % drug content shows that product were stable over the period for month. Thus it can be concluded that silk fibroin could be successfully used to stabilize theromosensitive therapeutics. In comparison fibroin seems to stabilize labile drugs efficiently reducing production cost and at lower toxicity risk. Thus, natural silk fibroin is a promising excipient to be used as a stabilizer because of its cryopreserving properties.

Key words: Silk fibroin, Tenofovir Alafinamide Fumarate, Stabilization, Freeze dying.

 

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The Official Journal of Association of Pharmaceutical Teachers of India (APTI)
(Registered under Registration of Societies Act XXI of 1860 No. 122 of 1966-1967, Lucknow)

Indian Journal of Pharmaceutical Education and Research (IJPER) [ISSN-0019-5464] is the official journal of Association of Pharmaceutical Teachers of India (APTI) and is being published since 1967.

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IJPER uses reference linking service using Digital Object Identifiers (DOI) by Crossref. Articles from the year 2013 are being assigned DOIs for its permanent URLs