Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-5241EnglishN2023March20Pharmaceutical SciencesPreclinical Drug Development Process: Formulation and Development Aspects English0110Mojabir Hussen AnsariEnglishMojabir Hussen Ansari, Assistant Professor, Institute of pharmaceutical sciences (Department of Chemistry), J. S. University, Shikohabad, Firozabad 283135, Uttar Pradesh, India.https://doi.org/10.31782/IJMPS.2023.13301Drug discovery and development process aims to make available new pharmacological entities to prevent, treat, mitigate or cure disease in a safe and effective manner. It involves rigorous testing and optimization of selected compounds to identify the drug that is most effective. Drug development starts with a target identification and validation, followed by drug candidate (hits) discovery, and lead drug (compound with favourable pharmaceutical, safety, efficacy and pharmacokinetic profile) selection and optimization then preclinical research, clinical research, FDA drug review, FDA post-market drug safety monitoring. In the stage of preclinical study, pharmaceutical preformulation and development and toxicity studies are the major concerns. The chapter focuses on preclinical formulations stressing upon different preclinical formulation strategies and deciphers the understanding of formulation approaches that could be employed. During preformulation studies the parameters evaluated are: solubility in different media and solvents, dissolution of the active pharmaceutical ingredient (API), accelerated stability studies under various conditions, solid state properties (polymorphs, particle size, particle shape, etc.), formulation development of new chemical entity (NCE),optimization of existing formulations, process development for selected dosage form, novel formulations for improved delivery of existing dosage forms, controlled release and sustained release formulations, micro and nano formulations, partition coefficient, pKa determination. It also emphasizes on Pharmacokinetic studies. The chapter also provides detailed information related to a vast pool of excipients available which is of immense help in designing preclinical formulations. A light is thrown on key aspects of preclinical formulation development by cited examples. 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Radiance Research AcademyInternational Journal of Current Research and Review2231-21960975-5241EnglishN2023March20Pharmaceutical SciencesDevelopment of Anti-Acne Topical Gel Formulation Containing Herbal Extract     English1116Anupama YadavEnglish Manorama RatreEnglishManorama Ratre, Assistant Professor, Department of Pharmacognosy, School of Pharmacy, Chouksey College of Engineering, NH-49, Masturi - Jairamnagar Road, Lalkhadan, Bilaspur 495004, Chhattisgarh, Indiahttps://doi.org/10.31782/IJMPS.2023.13302Systemic and topical antimicrobials are effective in the treatment of inflammatory acne vulgaris; however, widespread use of these agents is becoming increasingly associated with the emergence of resistant pathogens raising concerns about microorganism resistance and highlighting the need for alternative non-antimicrobial agents for the treatment of acne. Several multinational companies like Lakme Cosmetics Ltd., Lotus Ltd., Ayur Healthcare Ltd., Patanjali Ayurveda, etc. have started developing anti-acne products which contain multiple extracts of common Indian plants. The study aims to develop herbal gel formulations containing Bougainvillea glabra extract (aqueous, methanol, ethyl acetate, and petroleum ether) for the treatment of acne. The formulations were comprehensively evaluated for Physical evaluation, Washability, Skin irritation test, Spreadability, pH, Viscosity, Extrudability, Swelling index, and Accelerated stability studies as per the standard methods. Amongst all the formulations studied, batch F2 was found optimum for all the parameters. The extraction yield was found to be 11.21%. Bougainvillea glabra aqueous extract showed low anti-bacterial activity whereas both Bougainvillea glabra methanol extract and Bougainvillea glabra ethyl acetate extract expressed moderate anti-bacterial activity with average MIC value against E. coli and B. subtilis. In contrast to them, the petroleum ether extract of Bougainvillea glabra presented highest anti-bacterial activity, however, the activity was less pronounced than the standard drug Clindamycin. The formulations (F1-F4) represented alike results with that of the extracts and expressed lesser activity as compared to the marketed herbal product. EnglishBougainvillea glabra, Formulations, Acne, Characterization, Antimicrobial, Extracthttp://ijcrr.com/abstract.php?article_id=221http://ijcrr.com/article_html.php?did=2211. A. Vats and P. Sharma, “Formulation & evaluation of topical anti acne formulation of coriander oil,” International Journal of Pharmacy and Pharmaceutical Science Research, vol. 2, no. 3, pp. 61–66, 2012. 2. A. J. Hayes and B. Markovic, “Toxicity of Australian essential oil Backhousia citriodora (Lemon myrtle). Part 1. Antimicrobial activity and in vitro cytotoxicity,” Food and Chemical Toxicology, vol. 40, no. 4, pp. 535–543, 2002. 3. H. Azimi, M. Fallah-Tafti, A. A. Khakshur, and M. Abdollahi, “A review of phytotherapy of Acne vulgaris: perspective of new pharmacological treatments,” Fitoterapia, vol. 83, no. 8, pp. 1306–1317, 2012. 4. C. Hsu, T.-H. Tsai, Y.-Y. Li,W.-H.Wu, C.-J. Huang, and P.- J. Tsai, “Wild bitter melon (Momordica charantia Linn. var. abbreviata Ser.) extract and its bioactive components suppress Propionibacterium acnes-induced inflammation,” Food Chemistry, vol. 135, no. 3, pp. 976–984, 2012. 5. J. Saising and S. P. Voravuthikunchai, “Anti Propionibacterium acnes activity of rhodomyrtone, an effective compound from Rhodomyrtus tomentosa (Aiton) Hassk. leaves,” Anaerobe, vol. 18, no. 4, pp. 400–404, 2012. 6. S. Fu, C. Sun, X. Tao, and Y. Ren, “Anti-inammatory effects of active constituents extracted from Chinese medicinal herbs against Propionibacterium acnes,” Natural Product Research, vol. 26, no. 18, pp. 1746–1749, 2012. 7. V. Patil, A. Bandivadekar, and D. Debjani, “Inhibition of Propionibacterium acnes lipase by extracts of Indian medicinal plants,” International Journal of Cosmetic Science, vol. 34, no. 3, pp. 234–239, 2012. 8. M. Kanlayavattanakul and N. Lourith, “Therapeutic agents and herbs in topical application for acne treatment,” International Journal of Cosmetic Science, vol. 33, no. 4, pp. 289–297, 2011. 9. R. K. Chaudhuri and F. Marchio, “Bakuchiol in the management of acne-affected skin,” Cosmetics & Toiletries Magazine, vol. 126, no. 7, pp. 502–510, 2011. 10. T. Mahmood, N. Akhtar, B. A. Khan, H. M. S. Khan, and T. Saeed, “Outcomes of 3% green tea emulsion on skin sebum production in male volunteers,” Bosnian Journal of Basic Medical Sciences, vol. 10, no. 3, pp. 260–264, 2010. 11. 94. Shivhare, R. S., Kamble, M. A., Mahapatra, D. K., Ingole, A. R., & Baheti, J. R. (2018). Development of mosquito repellant gel formulations from various natural volatile oils: comparative study with the marketed formulation odomos®. Journal of Drug Delivery and Therapeutics, 8(6), 106-110. 12. Roy, S., Bose, S., Sarkar, D., Mandal, S., Sarkar, S., & Mandal, S. K. (2020). Formulation and evaluation of anti-acne gel containing Murraya koeinigii extract. International Journal of Current Pharmaceutical Research, 108-113. 13. Prasad, S. B., & Bist, M. (2018). In vitro anti acne activity of methanolic extract of dried fruit of Embelia ribes. International Journal of Pharmaceutical Quality Assurance, 9(02), 148-152.