Comparative analysis of sterility and active pharmaceutical ingredient content in imported and locally manufactured prednisolone and chloramphenicol eye drops. (Record no. 28829)

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005 - DATE AND TIME OF LATEST TRANSACTION
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028 ## - PUBLISHER OR DISTRIBUTOR NUMBER
Source Wurzburg Road 35, Premises, Post Code: 33102 |
Source P. O. Box 1464 Mwanza, Tanzania |
Source Phone: (255) 28-298-3384 |
Source Fax: (255) 28-298-3386 |
Source Email: vc@bugando.ac.tz |
Source Website: www.bugando.ac.tz
040 ## - CATALOGING SOURCE
Transcribing agency ddc
041 ## - LANGUAGE CODE
Language code of text/sound track or separate title English
Language code of text/sound track or separate title Kiswahili
100 ## - MAIN ENTRY--PERSONAL NAME
Relator term CUHAS/BP/3001298/T/20
Fuller form of name Aniceth Hansfrid Kabagambe
245 ## - TITLE STATEMENT
Title Comparative analysis of sterility and active pharmaceutical ingredient content in imported and locally manufactured prednisolone and chloramphenicol eye drops.
260 ## - PUBLICATION, DISTRIBUTION, ETC.
Place of publication, distribution, etc. Mwanza, Tanzania |
Name of publisher, distributor, etc. Catholic University of Health and Allied Sciences [CUHAS-Bugando] |
Date of publication, distribution, etc. 2024.
300 ## - PHYSICAL DESCRIPTION
Extent Includes References
520 ## - SUMMARY, ETC.
Summary, etc. Abstract:<br/><br/><br/>"Introduction: The quality of finished pharmaceutical products, including ophthalmic preparations, depends on good manufacturing practices, adherence to the established standard operating procedures, and availability of clean room requirements in manufacturing facilities. Inability to comply with these requirements leads to poor quality of the products. This study aimed to determine the sterility level and API content of imported and locally manufactured prednisolone and chloramphenicol eye drops<br/><br/>Methods: This laboratory-based analytical study was conducted at Tanzania Medicine and Medical Devices Authority (TMDA) laboratory, Mwanza, Tanzania. Imported chloramphenicol and prednisolone eye drop samples were obtained from community pharmacies in Nyamagana, Mwanza whereas, the locally manufactured samples of the same were obtained from Kilimanjaro Christian Medical Centre. Prednisolone and Chloramphenicol eye drop samples were analysed by membrane filtration and HPLC methods for sterility and API content, respectively.<br/><br/>Results and Discussion: All prednisolone eye drop samples were found to be sterile whereas, two samples out of four, for chloramphenicol eye drops, failed the assay test, according to pharmacopoeia standards. Locally manufactured chloramphenicol eye drops passed the assay test which suggests that local manufacturers are capable of producing high-quality and reliable pharmaceutical products.<br/><br/>Conclusion: All prednisolone eye drop samples were found to be sterile whereas only two chloramphenicol eye drop samples passed the assay test. The TMDA should withdraw from the market, chloramphenicol eye drops which failed the assay test."<br/>
600 ## - SUBJECT ADDED ENTRY--PERSONAL NAME
General subdivision Medicinal Chemistry and Pharmacognosy
700 ## - ADDED ENTRY--PERSONAL NAME
Fuller form of name Tanga Yango Mafuru
856 ## - ELECTRONIC LOCATION AND ACCESS
Public note Research Report Submitted in Partial Fulfilment for The Award of Bachelor of Pharmacy Degree of The Catholic University of Health and Allied Sciences.
942 ## - ADDED ENTRY ELEMENTS (KOHA)
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Koha item type UNDERGRADUATE DISSERTATIONS
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          MWALIMU NYERERE LEARNING RESOURCES CENTRE-CUHAS BUGANDO MWALIMU NYERERE LEARNING RESOURCES CENTRE-CUHAS BUGANDO 09/23/2024   20240923092349.0 09/23/2024 09/23/2024 UNDERGRADUATE DISSERTATIONS
Catholic University of  Health and Allied Sciences - CUHAS
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