Aliyah Moin, M (2012) To Study and to Evaluate the Requirements Required to Propose an Alternate Api for an Approved Drug Product in USFDA. Masters thesis, Adhiparasakthi College of Pharmacy, Melmaruvathur.
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Abstract
Tablets are tamper proof solid unit dosage forms containing medicament or mixture of medicaments and excipients compressed or molded into solid cylindrical shape having either flat or convex surfaces. The tablet must be sufficiently strong and resistant to shock, abrasion, should withstand handling during manufacturing, packing, shipping, and use. Hardness and friability tests measure this property. Tablet must be uniform in weight and in drug content of the individual tablet. This is measured by the weight variation and content uniformity tests. The drug content of the tablet must be bioavailable. This property is measured by the dissolution test. Accurate bioavailability can be obtained from the drug levels in the blood after its administration. results obtained by both the API‟S were found to be similar. Impurities present in the drug were found unaltered in the HPLC chromatogram and peaks in the DSC thermogram of drug disintegrant physical mixture. The powder blend was prepared by blending various ingredients in mortar and pestle for 20 min and evaluated for bulk density, tapped density, carr‟s index, Hausner‟s ratio angle of repose.Immediate release tablet of Naproxen sodium was obtained by wet granulation method for both the API formulations. Formulations prepared composed of povidone, sodium starch glycolate as disintegrants, and microcrystalline cellulose as diluents. Hence by comparing the specification standards i.e certificate of analysis of both the approved API source , the certificate of analysis of alternate API source and dissolution profiles of both the API sources it can be concluded that the results of Alternate API source ie CHARIOTER is equivalent with that of the Approved API source. According to Alternate Vendor Guideline in regulatory point of view an alternate vendor for Active pharmaceutical ingredient can be approved if the specification standards and dissolution profile was same as compared with that of the already approved API source. Hence the formulation of Naproxen sodium can be done by using the alternate API source i.e, CHARIOTER. Further formulation was carried out using the API of APPROVED ALTERNATE source and 6 formulations were carried out. Out of the 6 formulations first 3 formulations were done using direct compression method and next 3 formulations were done by wet granulation method
| Item Type: | Thesis (Masters) |
|---|---|
| Uncontrolled Keywords: | Evaluate ; Alternate Api ; Approved Drug Product ; USFDA. |
| Subjects: | PHARMACY > Pharmaceutics |
| Depositing User: | Ravindran C |
| Date Deposited: | 07 Jul 2017 06:46 |
| Last Modified: | 10 Dec 2017 03:26 |
| URI: | http://repository-tnmgrmu.ac.in/id/eprint/1224 |
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