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Budhwar, Vikas
- Drugs Import Procedure in India:A Comprehensive Review
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Authors
Affiliations
1 Department of Pharmaceutical Sciences, Maharshi Dayanand University, Rohtak-124001, IN
2 Institute of Pharmaceutical Sciences, Kurukshetra University, Kurukshetra-136118, IN
3 Chamber No 126, District Court Complex, Rohtak-124001, IN
1 Department of Pharmaceutical Sciences, Maharshi Dayanand University, Rohtak-124001, IN
2 Institute of Pharmaceutical Sciences, Kurukshetra University, Kurukshetra-136118, IN
3 Chamber No 126, District Court Complex, Rohtak-124001, IN
Source
Research Journal of Pharmacy and Technology, Vol 12, No 2 (2019), Pagination: 869-872Abstract
The legal issue regarding the drugs imported in our country is briefly discussed in this review. Being a densely populated country, India has a wide scope in pharmaceutical industry for foreign countries to sell their drugs in Indian market. In India, the regulatory process of import of drugs is very complicated and it takes one year or more to get them to be sold in Indian market. The review contains suggestions to decrease the time period taken for import of drugs within the country as it is a vital factor to the companies’ revenue and growth. The study succinctly describes the process to get approval of import of pharmaceutical companies and makes the drugs easily and rapidly accessible to Indian patients.Keywords
Registration Certificate, License, Import, Drugs Import, Drugs Export.
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- Enhancement of Stability Profile of Aspirin Through Cocrystallization Technique
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Authors
Affiliations
1 Department of Pharmaceutical Sciences, Maharshi Dayanand University, Rohtak -, IN
2 University Institute of Pharmaceutical Sciences, Kurukshetra University, Kurukshetra,, IN
1 Department of Pharmaceutical Sciences, Maharshi Dayanand University, Rohtak -, IN
2 University Institute of Pharmaceutical Sciences, Kurukshetra University, Kurukshetra,, IN
Source
Research Journal of Pharmacy and Technology, Vol 15, No 2 (2022), Pagination: 768-772Abstract
Cocrystallization process is a well-known technique for altering the pharmaceutical properties of drugs without modifying their actual pharmacological actions. Availability of a number of potential coformers make this technique more useful for implementation in pharmaceutical research area on newer and older API’s having pharmaceutical issues like poor solubility, stability profiles etc. Aspirin is a long-known antipyretic and antiinflammatory drug belonging to BCS Class II having poor aqueous solubility. This API undergoes hydrolysis at higher temperature and in humid environment with the resultant degradation products being salicylic acid and acetic acid. Cocrystalization technique could be useful for improving its stability profile as the physicochemical properties of drugs get modified by their cocrystallization with coformers having better thermal stability as well higher solubility profile than API’s. In this study, aspirin and benzoic acid have been cocrystallized in a fixed stochiometric ratio (1:2) for improving its stability issues. Differential Scanning Calorimetry (DSC), Infra-Red spectroscopy technique (FTIR) and X-ray Diffraction (XRD) technique were used for analysis of cocrystals. Dissolution study was performed which revealed an improved dissolution profile of cocrystals compared to pure drug aspirin. Accelerated stability study was performed as per ICH guidelines for 6 months and stability profile of drug and cocrystals were compared by using HPLC technique, which exhibited a better stability profile of cocrystals compared to pure drug.Keywords
Cocrystals, Benzoic Acid, Stability Study, Aspirin, HPLC.References
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