Development and characterization of topical analgesic ointment - from laboratory to production scale

Md Adib, Noor Adibah and Chatterjee, Bappaditya and Mandal, Uttam Kumar and Mohamed, Farahidah (2016) Development and characterization of topical analgesic ointment - from laboratory to production scale. In: 2nd International Conference on Industrial Pharmacy (ICIP 2016), 15th-16th Aug. 2016, Kuantan, Pahang. (Unpublished)

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Abstract

The purpose of this study was to scale up an ointment formulation containing 25% w/w methyl salicylate, developed via 300-g laboratory batches to 45-kg batch sizes in a homogenize mixer. Method: The ointment was manufactured by fusion method in a homogenous mixer. Characterization was conducted for assay of ingredients by a validated GC-FID method, physicochemical properties and microbial limit test. Further, optimized formulation was scaled up at large scale. Result: The desired analgesic ointments were developed and evaluated which contains petrolatum base (30%), Beeswax 1540 (20%) , methyl salicylate (10%), Menthol crystal (5 %),Camphor powder (5 %). The drug content were within specification. The stable formulation was observed during laboratory scale as well as at production scale. Successful scale up for 45kg batches were carried out. Conclusion: A topical analgesic ointment was developed and successfully scaled up that can be commercialized after meeting relevant regulatory requirements.

Item Type:	Conference or Workshop Item (Other)
Additional Information:	6923/52029
Uncontrolled Keywords:	topical analgesic ointment
Subjects:	R Medicine > RS Pharmacy and materia medica
Kulliyyahs/Centres/Divisions/Institutes (Can select more than one option. Press CONTROL button):	Kulliyyah of Pharmacy > Department of Pharmaceutical Technology
Depositing User:	Dr. Uttam Kumar Mandal
Date Deposited:	30 Sep 2016 10:37
Last Modified:	30 Sep 2016 10:37
URI:	http://irep.iium.edu.my/id/eprint/52029

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