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Published on:April 2019
Indian Journal of Pharmaceutical Education and Research, 2019; 53(2s):s193-s203
Original Article | doi:10.5530/ijper.53.2s.66

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


Authors and affiliation (s):

Pooja Gajanan Mirajkar, Ashok Ananda Hajare*

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

Abstract:

Aim: 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). Materials and Methods: On the basis of literature reviewed various lyophilized formulations of TAF using silk fibroin as a stabilizer were prepared. Lyophilized formulations were optimized by analyzing for % drug content, % moisture retention and appearance of lyophilizate and further investigated by using modern techniques such FT-IR, XRD and DSC. Formulations were tested to confirm suitability of silk fibroin to stabilize TAF during lyophilization. Initially for achieving desirable product features the fibroin concentration was optimized. The optimized concentration of fibroin was compared with commonly used cryoprotectants such as mannitol and sucrose. The process efficiency of fibroin as cryoprotectant was compared using product features. Results: Product features and stabilization efficiency of fibroin was lower than mannitol where as it was better than sucrose. The short term stability study retained drug to desired strength indicating lyophilized products stability over the period of a 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 due of its cryopreserving properties.

Key words: Silk fibroin, Stabilizer, Tenofovir Alafinamide Fumarate, Freeze drying.

 

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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