Volume : 12, Issue : 03, March – 2025
Title:
DRUG DEVELOPMENT AND FORMULATION ON EXPIRED DRUG
Authors :
Chetan S.Bajare, Mohamad Ashraf , Nandakishor B. Deshmukh, and Dr. Swati P. Deshmukh
Abstract :
The issue of expired medications presents both a challenge and an opportunity in the pharmaceutical sector. While traditionally considered unsafe or ineffective, recent research highlights the potential of expired drugs for reuse, repurposing, and reformulation. This paper explores the chemical, physical, and microbial changes that occur in drugs post-expiration and assesses their implications for safety, efficacy, and environmental impact. It also examines current regulatory frameworks for the disposal and redevelopment of expired pharmaceuticals, emphasizing the need for global harmonization. Advanced techniques such as high-throughput screening, computational modeling, and stability testing are discussed as tools for evaluating the potential reuse of expired drugs. Furthermore, the paper outlines the critical factors influencing drug degradation, including storage conditions, formulation types, and packaging materials. Emphasis is placed on the growing interest in sustainable healthcare practices through effective drug recycling strategies. By exploring these aspects, this study advocates for structured redevelopment approaches and responsible pharmaceutical waste management, contributing to public health and environmental protection.
KEYWORDS: Expired drugs, pharmaceutical waste, drug stability drug repurposing, chemical degradation, drug disposal regulatory guidelines, environmental Impact,Reformulation,Drug expiry Date,Drug safety
Cite This Article:
Please cite this article in press Chetan S.Bajare et al., Drug Development And Formulation On Expired Drug., Indo Am. J. P. Sci, 2025; 12(05).
Number of Downloads : 10
References:
1. Castensson, S. Pharmaceutical Waste. In Pharmaceuticals in the Environment; Springer: Berlin/Heidelberg, Germany, 2008; pp. 489–499.
2. Rawlins, E. A. Pharmaceuticals: Stability Testing and Shelf Life. Wiley; 2003.
3. D. N. G. (Editor). Good Manufacturing Practice for Pharmaceuticals: A Plan for Total Quality Control. CRC Press; 2010
4. A. T. Florence & D. A. Attwood. Drug Stability: Principles and Practices, 3rd Edition. Springer Science & Business Media; 2006.
5. World Health Organization (WHO). Good Manufacturing Practices: Main Principles for Pharmaceutical Products. Geneva, Switzerland: WHO; 2007.
6. Ruhoy, I.S.; Haughton, C.G. Beyond the medicine cabinet: An analysis of where and why medications Accumulate. Environ. Int. 2008
7. Ariffin, M.; Zakili, T.S.T. Household Pharmaceutical Waste Disposal in Selangor, Malaysia—Policy, Public Perception, and Current Practices. Environ. Manag. 2019.
8. Cohen LP, “Safe and effective. Many medicines prove potent for years past their expiration dates,” New York Times. March 28, 2000
9. Lueck S, “Drug prices far outpace Inflation,” Wall Street Journal. July 10, 2003.
10. IgelhartJK, ”Good science and the Marketplace for drugs: a conversation with Jean-Pierre Garnier,” HealthAff, 22: 119-127, 2003
11. Weber, F.-A.; Carius, A.; Grüttner, G.; Silke, H.; Ebert, I.; Hein, A.; Küster, A.; Rose, J.; Koch-Jugl, J.;Stolzenberg, H.-C. Pharmaceuticals in the Environment—The Global Perspective Occurrence, Effects, and PotentialCooperative Action under SAICM; German Environment Agency: Berlin, Germany, 2014; p. 12.
12. Garey, K.W.; Johle, M.L.; Behrman, K.; Neuhauser, M.M. Economic consequences of unused medications inHouston, Texas. Ann. Pharmacother. 2004, 38, 1165–1168. [CrossRef] [PubMed]
13. Guirguis, K. Medications collected for disposal by outreach pharmacists in Australia. Pharm. World Sci. 2010,32, 52–58. [CrossRef] [PubMed]
14. Kolpin, D.W.; Blazer, V.S.; Gray, J.L.; Focazio, M.J.; Young, J.A.; Alvarez, D.A.; Iwanowicz, L.R.; Foreman, W.T.;Furlong, E.T.; Speiran, G.K.; et al. Chemical contaminants in water and sediment near fish nesting sites in the Potomac River basin: Determining potential exposures to smallmouth bass (Micropterus dolomieu). Sci.Total Environ. 2013, 443, 700–716. [CrossRef]
15. Fernando, D.M.; Tun, H.M.; Poole, J.; Patidar, R.; Li, R.; Mi, R.; Amarawansha, G.E.A.; Fernando, W.G.D.;Khafipour, E.; Farenhorst, A.; et al. Detection of Antibiotic Resistance Genes in Source and DrinkingWater Samples from a First Nations Community in Canada. Appl. Environ. Microbiol. 2016, 82, 4767–4775.[CrossRef] [PubMed]
16. Kim, S.; Aga, D.S. Potential ecological and human health impacts of antibiotics and antibiotic-resistantBacteria from wastewater treatment plants. J. Toxicol. Environ. Health Part B Crit. Rev. 2007, 10, 559–573.[CrossRef] [PubMed]
17. Robertson, J.; Barr, R.; Shulman, L.N.; Forte, G.B.; Magrini, N. Essential medicines for cancer: WHO Recommendations and national priorities. Bull. World Health Organ. 2016, 94, 735–742. [CrossRef]
18. Pharmaceuticals for Human Use (ICH). ICH Q1A (R2): Stability Testing of New Drug Substances and Products. Geneva, Switzerland: ICH; 2003.
19. O’Neill, H. P. Pharmaceutical Stability: A Practical Approach. Wiley-Blackwell; 2012.
20. U.S. Pharmacoepeial Convention. USP 41–NF 36. Rockville, MD: U.S. Pharmacoepeial Convention; 2018.
21. American Pharmaceutical Association (APhA). Remington: The Science and Practice of Pharmacy, 22nd ed. Philadelphia, PA: Lippincott Williams & Wilkins; 2012.
22. International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH Q1A (R2): Stability Testing of New Drug Substances and Products. Geneva, Switzerland: ICH; 2003.
23. Strohmeyer, G., & Roscher, E. The Stability of Pharmaceuticals: A Theoretical and Practical Guide. CRC Press; 2011.
24. Taylor JS, Lyon RC, Prasanna HR, Hussain AS. , “Stability profiles of drug products Extended beyond labeled expiration dates,” April 8, 2004.
25. Kramer, T.A.M, “ Commentary: Do Medications really expire ,”August 21,2003.
26. Raka, F. et al. (2020). “Factors Influencing the Stability of Pharmaceuticals.” International Journal of Pharmacy and Pharmaceutical Sciences, 12(1), 1-7. Available at: IJPP.