Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-5241EnglishN2023September30Pharmaceutical SciencesSystematic Approach of Autoclave Qualification: A Review     English0106Ashita R. TalekarEnglish Ajay G. PiseEnglishAshita R. Talekar, Department of Pharmaceutics Regulatory Affairs, Dadasaheb Balpande College of Pharmacy, Besa, Nagpur, Rashatrasant Tukadoji Maharaj Nagpur University, Nagpur (MS), India-440037https://doi.org/10.31782/IJMPS.2023.13901Autoclave used to sterilize items that can withstand moisture and high temperature. An autoclave or steam sterilizer is used to sterilize surgical equipment, laboratory instruments, pharmaceutical items, and other materials. Autoclave validation or qualification is mandatory to achieve a high level of sterility or quality of the product. Quality is the primordial intention of the industry and its product manufacturing. As part of the GMP, qualification is mandatory. Each company should identify what qualification work is required to prove the critical aspects of their particular operation control. Autoclaving is the most effective and efficient means of sterilization. Sterilization is a process to remove, kills, or deactivate all the microorganisms such as bacteria and spores. The purpose of this study is to give a systematic approach required for the qualification of the autoclave which contains USR, DQ, IQ, PQ, and OQ and also contains the factor that affects the sterilization and evaluation parameter test. EnglishAutoclave Qualification, Performance Evaluation Testhttp://ijcrr.com/abstract.php?article_id=233http://ijcrr.com/article_html.php?did=2331. Autoclave sterilization process guide. Tuttnauer. Blog. Accessed on: 14/12/2022 Available from: https://tuttnauer.com/blog/autoclave. 2. Who invented the autoclave machine? Steries Health Care. Accessed on: 14/12/202Available from:[https://www.steris.com/ healthcare/knowledge-center/sterile-processing/everythingabout- autoclaves]. 3. Oyawale.F.A, Olaye.A.E. Design construction of autoclave. The Pacific Journal of Science and Technology. Volume 8(2); November 2007; 224-230. 4. Judelson, H. 2004. “Operation of the Autoclaves”[ Available from: http://138.23.152.128/protocols/autoclave%20operation. pdf] 5. Dion M. and Parker W. Steam Sterilization Principles; Pharmaceutical Engineering; volume 3(6); November/December 2013; 1-8. 6. N. Vishal Gupta, Sterilization of porous loads by hphv steam sterilizer: A Review, International Journal of Pharm Tech Research, vol.9(3), pp 374-386. 7. Mondal TK. Research paper Guidance for periodic Qualification of steam sterilization. Journal of Global Biostatics, 2019; 8(1): 5739-59. 8. D value, Z value, and F value. Pharma State academy. Blog. Accessed on: 27/02/2023. Available from: https://pharmastate. academy/d-value-z-value-and-f-value/#:~:text=The%20z value%20of%20an,an%20organism%20to%20differing%20 temperature. 9. European Commission. Annex 15 Qualification and Validation. EU Guidelines for Good 10. Good Manufacturing Practice for Medicinal Product for Human and Veterinary Use. Eudralex Volume 4 March 2015. 11. Choudhary AN, Sehgal T. A review on pharmaceutical validation and its implication, International Journal of Pharmaceutical and biological sciences, Vol8(2), APR-JUNE,2018:117-126. 12. PDA Technical Report no-48, Moist Heat Sterilizer Systems: Design, Commissioning, Operation, Qualification, and Maintenance 2010. 13. Kakad SB, Kolhe MH, Dukre TP. A Review on Pharmaceutical Validation. International Journal of Pharmaceutical Quality Assurance. 2020;11(3):338-342. 14. Suvidha J. Mishra, Sweta Goel, Dr. Kapil Joshi. Process performance qualification (an effective tool to ensure product quality and patient safety). World Journal of Pharmaceutical Research.2022;11(9):501-517. 15. HTM 2010:1998- “Health Technical Memorandum 2010 Sterilization- Part 3: Validation and verification.” Page 67-72(Guidelines) 16. “Sterilization - Steam sterilizers - Large sterilizers, Section No-24.0, Steam quality test” - EN 285: 2006 (British Standard Guidelines) 17. “Sterilization - Steam sterilizers - Large sterilizers, Air leakage flow rate, Page no 23.” - EN 285: 2006 (British Standard Guidelines) 18. “Sterilization - Steam sterilizers - Large sterilizers, Section No- 8.3.2.1.” - EN 285: 2006 (British Standard Guidelines) 19. Heat distribution study. ALPF Medical Research. Accessed on: 25/02/2023. Available from: https://www.alpfmedical.info/ process-validation/c-heatdistribution-studies.html 20. N. Vishal Gupta, Shukshith K.S. Qualification of Autoclave, International Journal of Pharm Tech Research, vol.9(4), pp 220- 226. 21. HTM 2010:1998- “Health Technical Memorandum 2010 Sterilization- Part 3: Validation and verification.” Page 92(Guidelines) 22. Chavan G. C., Gangarde A. M., Jaiswal N. R., Sarkhare V.G., Pawar R.S., Nomulwar N.R., Performance qualification of Industrial steam sterilizer (Autoclave).International Journal of Research and Analytical Review. 2022. Volume 9(3): page no. 512-519 23. Chaukate M.A., Bade A.S., Salunke S.R. Complete Review of qualification of autoclave. International Journal of Creative Research Though. 2022. Volume10(1): page no. 360-363.

Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-5241EnglishN2023September30Pharmaceutical SciencesDevelopment and Characterization of Domperidone Containing Medicated Chewing Gum Formulations     English0712Jyoti Kiran SahuEnglish Suruchi PrasadEnglishMs. Suruchi Prasad, M. Pharm, Assistant Professor, Department of Pharmaceutics, School of Pharmacy, Chouksey Engineering College, Bilaspur 495004, Chhattisgarh, Indiahttps://doi.org/10.31782/IJMPS.2023.13902Chewing gums are mobile drug delivery systems, with a potential for administering drugs either for local or systemic absorption via buccal route. It can be administered discreetly without water. Medicated Chewing Gums contains gum base along with antiemetic agent which is intended to chew not to be swallowed. Domperidone is a dopamine receptor antagonist used as a peristaltic stimulant and anti-emetic agent for dyspepsia, indigestion, epigastric pain, nausea, and vomiting. It is a specific blocker of dopamine receptors. It speeds gastrointestinal peristalsis, causes prolactin release, and is used as antiemetic and tool in the study of dopaminergic mechanisms. It is a small molecule, approved, investigational, vet approved with molecular weight of 425.911 and molecular formula of C22H24ClN5O2. These formulations contain domperidone maleate, gum base, sorbitol, sucrose, lactose, calcium carbonate, and talc. The medicated chewing gums were prepared by the direct compression method. The prepared formulations were evaluated for various pre-compression and post-compression parameters. From the results, it is concluded that the chewing gum containing domperidone maleate will be the potential dosage form for the treatment of chemotherapy induced nausea and vomiting. EnglishDomperidone maleate, Medicated Chewing gum, Formulation, Development, Characterization, Stabilityhttp://ijcrr.com/abstract.php?article_id=234http://ijcrr.com/article_html.php?did=2341. Jacobsen J, Christrup LL, Jensen NH. Medicated chewing gum. Am J Drug Deliv. 2004;2(2):75-88. 2. Desai TR, Dedakiya AS, Bandhiya HM, Patel VP. A. medicated chewing gum: A review. Int J Univ Pharm Life Sci. 2011;1:111- 28. 3. Aslani A, Rostami F. Medicated chewing gum, a novel drug delivery system. J Res Med Sci. 2015;20(4):403-11. 4. Chaudhary SA, Shahiwala AF. Medicated chewing gum–a potential drug delivery system. Exp Opin Drug Deliv. 2010;7(7):871-85. 5. Kumar R, Solanki P, Chandra A. Medicated chewing gum-a novel drug delivery system: An updated review. Am J Adv Drug Deliv. 2014;2(3):434-50. 6. Jadhav AV, Mohite SK. A comprehensive review on: medicated chewing gum. J Curr Pharm Res. 2014;4(3):1215-24. 7. Zhang H, Zhang J, Streisand JB. Oral mucosal drug delivery. Clin Pharmacokinet. 2002;41(9):661-80. 8. Tortora GJ, Derrickson BH. Principles of anatomy and physiology. Philadelphia: John Wiley & Sons; 2018. 9. Sembulingam K, Sembulingam P. Essentials of Medical Physiology. New Delhi: JayPee Brothers Medical Ltd.; 2012. 10. Waugh A, Grant A. Ross & Wilson Anatomy and physiology in health and illness. Amsterdam: Elsevier Health Sciences; 2014. 11. Gururajbhat A, Kulyadi GP, Tippavajhala VK. A comprehensive review on formulation, preparation, evaluation and applications of Medicated Chewing Gum. Res J Pharm Technol. 2021;14(3):1760-6. 12. Khatun S, Sutradhar KB. Medicated chewing gum: An unconventional drug delivery system. Int Curr Pharm J. 2012;1(4):86-91. 13. Aslani A, Ghannadi A, Rostami F. Design, formulation, and evaluation of ginger medicated chewing gum. Adv Biomed Res. 2016;5:130.