Open Access Open Access  Restricted Access Subscription Access
Open Access Open Access Open Access  Restricted Access Restricted Access Subscription Access

Implication of Data Obtained from Real Time Stability Studies of Pharmaceutical Preparations


Affiliations
1 Department of Quality Control, Jesil Pharmaceutical Industries Limited, Minna,, Nigeria
2 Department of Microbiology, Bayero University, Kano,, Nigeria
3 Department of Quality Control, Jesil Pharmaceutical Industries Limited, Minna,
4 Department of Quality Control, LeyJay Pharmaceuticals Limited, Minna,, Nigeria
5 Department of Microbiology, Federal University of Technology, Minna,, Nigeria
6 Department of Applied Biology, College of Science and Technology, Kaduna Polytechnic, Kaduna,, Nigeria
7 Department of Plant and Environmental Biology, Kwara State University, Malete, Ilorin,, Nigeria
     

   Subscribe/Renew Journal


The major reason for carrying out stability studies of a drug product is to establish the shelf life of a drug during the period of storage so as to guarantee its quality, effectiveness and safety. Real time stability studies data from 2018-2022 were obtained from selected pharmaceutical industries located within North Central, Nigeria. The analysis of variance (ANOVA) of the data obtained for the real time stability studies was carried out using IBM SPSS Statistics Version 23. The results obtained showed that both chemical and microbiological parameters checked were within the pre-set specifications despite the changes in the results as the storage increases due to environmental factors such as: temperature, humidity, light, exposure to oxygen and container –closure system used for the packaging of the drug product. Pathogenic bacteria such as: Escherichia coli, Staphylococcus aureus, Salmonella typhimurium and Pseudomonas aeruginosa recorded 0.00 cfu/ml and the values obtained for total viable aerobic mesophilic bacteria plate count and fungi were within the pre-set specifications while Staphylococcus aureus and Candida albicans were sensitive to Methylated Spirit. There was a significant difference in the data analysed (P<0.05). The implication of this study is that the drug product may not be stable if the shelf life increases beyond what was stated for them. Hence, these results provided clues to how the quality of the product changes with time under different environmental factors (temperature, relative humidity, exposure to oxygen and light) and the interaction between the drug product and container-closure system used. This study suggests the need for pharmaceutical industries to continuously carry out stability studies of drug products in order to know the changes that may likely occur during the storage and to establish the shelf life of the drug product.

Keywords

Real Time Studies, Pharmaceutical Preparations, Stability, Shelf Life.
Subscription Login to verify subscription
User
Notifications
Font Size


  • Kumar KA, Uppala PK, Radha Devi JB, Murali Krishna B. Formulation and Evaluation of Stable Aqueous Extract of Polyherbal Multipurpose Face Cream. Research Journal of Topical and Cosmetic Sciences.2017; 8 (1): 12-18.
  • NagaRaju P, Sneha A, Ramya GG, Sneha S, Vykuntam U. Stability Studies of Pharmaceutical Products. World Journal of Pharmaceutical Research. 2019; 8 (1): 479-492.
  • Nagajyothi M, Pramod K, Bijin EN, Baby JN, Valsalakumari J. Accelerated Stability Studies of Atorvastatin Loaded Nanoemulsion Gel. Asian Journal of Pharmacy and Technology. 2015; 5 (3):188-191.
  • Arunachalam A, Shankar M. Stability Studies: A Review. Asian Journal of Pharmaceutical Analysis and Medicinal Chemistry. 2013; 1 (4): 184 - 195.
  • Panda A, Kulkarni S, Tiwari R. Stability Studies: An Integral Part of Drug Development Process. International Journal of Pharmaceutical Research and Bio-Science. 2013; 2: 69-80.
  • Gharge V, Pawar P. Stability of Aqueous and Oily Ophthalmic Solutions of Moxifloxacin. Asian Journal of Pharmacy and Technology. 2018; 8 (1): 29-34.
  • Singh S. Stability testing during product development in Jain NK Pharmaceutical product development, CBS publisher and distributors, India, 2000, 272-293.
  • Tembhare E, Gupta KR,, Umekar MJ. An Approach to Drug Stability Studies and Shelf-life Determination. Archives of Current Research International. 2019; 19 (1): 1-20.
  • Iqbal ATI, Muhammed AS, Sofia A. Stability of Drugs and Drug Products. Faculty of Pharmaceutical Sciences, Baqai Medical University, Karachi, Higher Education Commission, Islamabad – Pakistan (Unpublished Thesis). 2016.
  • United States Pharmacopeia – USP. United States Pharmacopeia 39 – National Formulary 34, United States Pharmacopoeial Convention, Rockville, MD, USA. 2016.
  • Jadhav J, Mundhada D, Mujoriya R. Formulation Development and Evaluation of Gastro-Retentive Drug (Torsemide) Delivery System for Diuretic Drug. Asian Journal of Pharmaceutical Research 2015; 5 (3): 125-130.
  • Bajaj S, Singla D, Sakhuja N. Stability Testing of Pharmaceutical Products. Journal of Applied Pharmaceutical Science. 2012; 02 (03): 129-138.
  • Patel NN, Kothari CS. Critical review: Significance of Force degradation study with respect to current Pharmaceutical Scenario. Asian Journal of Research in Chemistry. 2013; 6(3): 286-296.
  • Anand BK, Kumudhavalli MV, Reddy KS, Jaykar B. Stability Indicating UV-Spectrophotometric Determination of Nevirapine in Pharmaceutical Dosage Form. Research Journal of Pharmacy and Technology. 2011; 4 (9): 1386-1388.
  • Carstensen JT. Drug Stability, Principles and Practices, Marcel Dekker, New York. 2000.
  • World Health Organization- WHO. Guidelines for stability testing of pharmaceutical products containing well established drug substances in conventional dosage forms. WHO Technical Report Series, No. 863. 1996, pp. 65-66.
  • Matthews RB. Regulatory Aspects of Stability Testing in Europe. Drug Development and Industrial Pharmacy. 1996; 25: 831-856.
  • Herbig A, Catherine MGC, Renard MGCC. Factors that impact the stability of vitamin C at intermediate temperatures in a food matrix. Food Chemistry. 2017; 220: 444-451.
  • Farah HS, Alhmoud JF, Al-Othman A, Alqaisi KM, Atoom AM, Shadid K, Shakya A, AlQaisi T. Effect of pH, Temperature and Metal Salts in Different Storage Conditions on the Stability of Vitamin C Content of Yellow Bell Pepper Extracted in Aqueous Media. Systematic Review in Pharmacy. 2020; 11 (9): 661-66
  • Sultana S, Mohammed S. A Review on Stability Studies of Pharmaceutical Products. International journal for Pharmaceutical Research Scholars. 2018; 7 (1): 28-49.
  • Thorat P, Warad S, Solunke R, Ashok S, Anagha B, Asha S. Stability Study of Dosage Form: An Innovative Step. World Journal of Pharmacy and Pharmaceutical Sciences. 2014; 3 (2): 1031-1050.
  • Ahirwar B. Evaluation of stability study of Ayurvedic formulation Vasavaleha. Asian Journal of Research in Pharmaceutical Sciences. 2013: 3 (1): 1-4.
  • Alqurshi A. Household storage of pharmaceutical products in Saudi Arabia; A call for utilising smart packaging solutions. Saudi Pharmaceutical Journal. 2020; 28 (4): 1411–1419.
  • Gupta R, Singh KK.. Stability Studies on a Cough Syrup in Plastic Containers. Indian Journal of Pharmaceutical Sciences. 2007; 69 (3), 408-413.
  • Gauthami R, Sudhakara RG, Anoop A, Gopal TK, Reddy CUM. Stability Studies of a Polyherbal Formulation, Urito under Accelerated Conditions. Research Journal of Pharmacognosy and Phytochemistry. 2011; 3 (3): 128-133.
  • National Agency for Food and Drug Administration and ControlNAFDAC (2016). Good Manufacturing Practice Guideline for Pharmaceutical Products. Abuja, Nigeria. 2016; 2016 ed: pp. 11- 12.
  • International Conference on Harmonization-ICH. Stability Testing for New Dosage Forms Annex to the ICH Harmonized Tripartite Guideline on Stability Testing for New Drugs and Products Q1C, ICH. 1996a.
  • ICH. Stability Testing: Photostability Testing of New Drug Substances and Products Q1B, ICH, Berlin. 1996b.
  • Manohar DK, Ganesh BV, Akshata SG, Asha MJ, Indrayani DR. Formulation and Evaluation of Polyherbal Shampoo. Research Journal of Topical and Cosmetic Sciences. 2018; 9(1): 1-3.
  • Noor R, Zerin N, Das KK. Microbiological quality of pharmaceutical products in Bangladesh: current research perspective. Asian Pacific Journal of Tropical Disease. 2015; 5 (4): 264-270
  • Mukhtar GI, Mukhtar MD, Magashi AM. Assessment of Microbial Contamination in Pediatric Oral Liquid Formulations Marketed in Katsina State, Nigeria. Bayero Journal of Pure and Applied Sciences. 2019; 12 (1): 657-662.
  • Chandrasekar R, Sivagami B. Formulation and Evaluation of a Poly Herbal Skin Care Cream containing Neem and Tulsi. Research Journal of Topical and Cosmetic Sciences. 2018; 9(1): 25-32.
  • Rashid I, Daraghmeh NH, Al Omari MM, Chowdhry BZ, Leharne SA, Hodali HA, Badwan AA. Magnesium Silicate. In: Harry G. Brittain, editor: Profiles of Drug Substances, Excipients and Related Methodology, Academic Press, Burlington. 2011; volume 36: pp. 241-285.
  • Roque F, Rama AN, Sousa JJ, Pina ME. Development and stability assessment of liquid paediatric formulations containing sildenafil citrate. Brazilian Journal of Pharmaceutical Sciences. 2013; 49 (2): 381-388.
  • Oyetade OA, Oyeleke GO, Adegoke BM, Akintunde AO. Stability Studies on Ascorbic Acid (Vitamin C) From Different Sources. IOSR Journal of Applied Chemistry. 2012; 2 (4): 20-24.

Abstract Views: 163

PDF Views: 0




  • Implication of Data Obtained from Real Time Stability Studies of Pharmaceutical Preparations

Abstract Views: 163  |  PDF Views: 0

Authors

Oloninefa, S. D
Department of Quality Control, Jesil Pharmaceutical Industries Limited, Minna,, Nigeria
Aisoni, J. E
Department of Microbiology, Bayero University, Kano,, Nigeria
Areo, A. J
Department of Quality Control, Jesil Pharmaceutical Industries Limited, Minna,
Akomolafe, D. O
Department of Quality Control, LeyJay Pharmaceuticals Limited, Minna,, Nigeria
Abalaka, M. E
Department of Microbiology, Federal University of Technology, Minna,, Nigeria
Alli, A. I
Department of Applied Biology, College of Science and Technology, Kaduna Polytechnic, Kaduna,, Nigeria
Adewumi, A. A
Department of Plant and Environmental Biology, Kwara State University, Malete, Ilorin,, Nigeria

Abstract


The major reason for carrying out stability studies of a drug product is to establish the shelf life of a drug during the period of storage so as to guarantee its quality, effectiveness and safety. Real time stability studies data from 2018-2022 were obtained from selected pharmaceutical industries located within North Central, Nigeria. The analysis of variance (ANOVA) of the data obtained for the real time stability studies was carried out using IBM SPSS Statistics Version 23. The results obtained showed that both chemical and microbiological parameters checked were within the pre-set specifications despite the changes in the results as the storage increases due to environmental factors such as: temperature, humidity, light, exposure to oxygen and container –closure system used for the packaging of the drug product. Pathogenic bacteria such as: Escherichia coli, Staphylococcus aureus, Salmonella typhimurium and Pseudomonas aeruginosa recorded 0.00 cfu/ml and the values obtained for total viable aerobic mesophilic bacteria plate count and fungi were within the pre-set specifications while Staphylococcus aureus and Candida albicans were sensitive to Methylated Spirit. There was a significant difference in the data analysed (P<0.05). The implication of this study is that the drug product may not be stable if the shelf life increases beyond what was stated for them. Hence, these results provided clues to how the quality of the product changes with time under different environmental factors (temperature, relative humidity, exposure to oxygen and light) and the interaction between the drug product and container-closure system used. This study suggests the need for pharmaceutical industries to continuously carry out stability studies of drug products in order to know the changes that may likely occur during the storage and to establish the shelf life of the drug product.

Keywords


Real Time Studies, Pharmaceutical Preparations, Stability, Shelf Life.

References