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...
| Main Authors: | , , , |
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| Format: | Proceeding Paper |
| Language: | English |
| Published: |
2016
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| Subjects: | |
| Online Access: | http://irep.iium.edu.my/52029/ http://irep.iium.edu.my/52029/13/52029.pdf |
| _version_ | 1848783981256900608 |
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| 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 |
| building | IIUM Repository |
| collection | Online Access |
| 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. |
| first_indexed | 2025-11-14T16:29:59Z |
| format | Proceeding Paper |
| id | iium-52029 |
| institution | International Islamic University Malaysia |
| institution_category | Local University |
| language | English |
| last_indexed | 2025-11-14T16:29:59Z |
| publishDate | 2016 |
| recordtype | eprints |
| repository_type | Digital Repository |
| 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 Proceeding Paper 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) |
| 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 |
| title | 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_short | 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 |
| topic | RS Pharmacy and materia medica |
| url | http://irep.iium.edu.my/52029/ http://irep.iium.edu.my/52029/13/52029.pdf |