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

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...

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Main Authors:	Md Adib, Noor Adibah, Chatterjee, Bappaditya, Mandal, Uttam Kumar, Mohamed, Farahidah
Format:	Conference or Workshop Item
Language:	English
Published:	2016
Subjects:	RS Pharmacy and materia medica
Online Access:	http://irep.iium.edu.my/52029/ http://irep.iium.edu.my/52029/13/52029.pdf

id	iium-52029
recordtype	eprints
spelling	iium-520292016-09-30T02:37:42Z http://irep.iium.edu.my/52029/ Development and characterization of topical analgesic ointment - from laboratory to production scale Md Adib, Noor Adibah Chatterjee, Bappaditya Mandal, Uttam Kumar Mohamed, Farahidah RS Pharmacy and materia medica 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. 2016 Conference or Workshop Item NonPeerReviewed application/pdf en http://irep.iium.edu.my/52029/13/52029.pdf 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)
repository_type	Digital Repository
institution_category	Local University
institution	International Islamic University Malaysia
building	IIUM Repository
collection	Online Access
language	English
topic	RS Pharmacy and materia medica
spellingShingle	RS Pharmacy and materia medica Md Adib, Noor Adibah Chatterjee, Bappaditya Mandal, Uttam Kumar Mohamed, Farahidah Development and characterization of topical analgesic ointment - from laboratory to production scale
description	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.
format	Conference or Workshop Item
author	Md Adib, Noor Adibah Chatterjee, Bappaditya Mandal, Uttam Kumar Mohamed, Farahidah
author_facet	Md Adib, Noor Adibah Chatterjee, Bappaditya Mandal, Uttam Kumar Mohamed, Farahidah
author_sort	Md Adib, Noor Adibah
title	Development and characterization of topical analgesic ointment - from laboratory to production scale
title_short	Development and characterization of topical analgesic ointment - from laboratory to production scale
title_full	Development and characterization of topical analgesic ointment - from laboratory to production scale
title_fullStr	Development and characterization of topical analgesic ointment - from laboratory to production scale
title_full_unstemmed	Development and characterization of topical analgesic ointment - from laboratory to production scale
title_sort	development and characterization of topical analgesic ointment - from laboratory to production scale
publishDate	2016
url	http://irep.iium.edu.my/52029/ http://irep.iium.edu.my/52029/13/52029.pdf
first_indexed	2023-09-18T21:13:46Z
last_indexed	2023-09-18T21:13:46Z
_version_	1777411425846689792

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

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