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Vol.3 , No. 4, Publication Date: Jun. 21, 2016, Page: 33-39
 with its generic brands that are commonly prescribed in Southern Nigeria. Ten generic brands of Omeprazole capsule were assessed relative to Losec<sup>®</sup>. Physicochemical tests were performed on all brand samples using standard methods. Weight uniformity, content of active ingredient and disintegration tests were performed on all the samples using Pharmacopoeial and other standard methods. The drug release profiles were evaluated <i>in-vitro</i> using a dissolution test apparatus. Of the 11 brands that were tested, (n=11, 100%) met the specifications for physicochemical properties, disintegration tests and drug release, (n=10, 90.9%) met the specification for weight uniformity while (n=9, 81.8%) brands complied with the specification for drug content. None of the samples were suspected to be counterfeit, based on visual inspection and assessment. Statistical evaluation of the results revealed remarkable inter-brand variations and significant differences between the generic brands and the innovator brand. This clearly raises a question about the interchangeability between the innovator brand and its generic counterparts and even among the generics themselves. It also highlights the need for proper assessment and monitoring of patients after performing generic substitution.&picture=http://www.aascit.org/aascit/decorators/img/journal/922.jpg)
| [1] | Okorie O., Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, University of Port Harcourt, Rivers State, Nigeria. |
| [2] | Azaka J. E., Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, University of Port Harcourt, Rivers State, Nigeria. |
| [3] | Amadi C. M., Department of Pharmaceutics and Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, University of Port Harcourt, Rivers State, Nigeria. |
Generic substitution and cost of different brands of drugs has been a major challenge between health care professionals and their patients especially in health institutions. There is a need to enlighten prescribers on the quality of generic drugs used in the hospitals so as to ensure that efficacious, cost-effective drugs are prescribed for the patients and hence, quality of life is improved. The proliferation of counterfeit and poor-quality drugs is a major public health problem in developing countries such as Nigeria. The objective of this study was to compare the Pharmaceutical quality of innovator brand of Omeprazole capsule (Losec®) with its generic brands that are commonly prescribed in Southern Nigeria. Ten generic brands of Omeprazole capsule were assessed relative to Losec®. Physicochemical tests were performed on all brand samples using standard methods. Weight uniformity, content of active ingredient and disintegration tests were performed on all the samples using Pharmacopoeial and other standard methods. The drug release profiles were evaluated in-vitro using a dissolution test apparatus. Of the 11 brands that were tested, (n=11, 100%) met the specifications for physicochemical properties, disintegration tests and drug release, (n=10, 90.9%) met the specification for weight uniformity while (n=9, 81.8%) brands complied with the specification for drug content. None of the samples were suspected to be counterfeit, based on visual inspection and assessment. Statistical evaluation of the results revealed remarkable inter-brand variations and significant differences between the generic brands and the innovator brand. This clearly raises a question about the interchangeability between the innovator brand and its generic counterparts and even among the generics themselves. It also highlights the need for proper assessment and monitoring of patients after performing generic substitution.
Keywords
Omeprazole Capsules, Quality Assurance, Generic Substitution, Inter-brand Variation, Public Health
Reference
| [01] | Mostafavi SA, Tavakoli N (2014). Relative bioavailability of omeprazole capsules after oral dosing. DARU. 12 (4): 146-50. |
| [02] | Walker R, Whittlesea K (2010). Clinical Pharmacy and therapeutics. Fifth edition. Churchill livingstone. |
| [03] | Drug bank omeprazole – www.drugbank.ca/drugs/DB00338 [accessed November, 2015]. |
| [04] | Prof Eyitayo Lambo (2006). Medicine prices in Nigeria; Prices people pay for medicine. |
| [05] | Thoma K, Bechtold K (1999). Influence of aqueous coatings on the stability of enteric coated pellets and tablets. European Journal of Pharmaceutics and Biopharmaceutics. 47: 39-50. |
| [06] | Matthew M, Gupta VD, Bailey RE (1995). Stability of omeprazole solutions at various pH values as determined using HPLC. Drug Dev. Ind. Pharm. 121: 965-971. |
| [07] | Ofner CM (2001). Crosslinking studies in gelatin capsules treated with formaldehyde and in capsules exposed to elevated temperature and humidity. Journal of Pharmaceutical Sciences, 90: 79-88. |
| [08] | Chang RK, Raghavan KS, Hussain MA (1998). A study on gelatin capsule brittleness: moisture transfer between the capsule shell and its content. Journal of pharmaceutical sciences. 87: 556-8. |
| [09] | El Sayed A, Boraie NA, Ismail FA, Khondagui EL (2007). Assessment of the pharmaceutical quality of omeprazole capsules brands marketed in Egypt. Eastern Mediterranean Health Journal. 13: 1427-37. |
| [10] | Khalil SAH, Barakat NS, Boraie NA (1991). Effect of package type on the in vitro release and chemical stability of amoxicillin capsules. Die Pharmazeutiche Industrie. 53: 698-701. |
| [11] | Garattini L, Tediosi F (2000). A comparative analysis of generics marketed in five European Countries. Health Policy. 51: 149-162. |
| [12] | Coyle S, Connolly DO (2009). Generic Substitution and the realities of equivalence. 5 (2). p. 4-5. |
| [13] | Matthew Mitchel (2009). Effect of health plan and physician clinic collaboration on increasing omeprazole use. UBM Medica network. |
| [14] | Enoche F, Florence DT, Olayinka J. (2010). An assessment of the quality of various brands of paracetamol tablets sold in the Nigerian capital city. Int. J. Biol. Chem. Sci. 4 (1): 115-21. |
| [15] | Akunyili D (2005). Counterfeit drugs and pharmacovigilance. The study of adverse drug reactions training course held at uppsala monitoring centre, Sweden. 1-64. |
| [16] | Erhun WO, Babalola OO, Erhun MO (2001). Drug Regulation and Control in Nigeria: The Challenge of Counterfeit Drugs. Journal of Health and Population in Developing Countries, 4 (2): 23-34. |
| [17] | Shakoor O, Taylor R, Behrens R. (1997). Assessment of the incidence of substandard drugs in developing countries. Tropical Medicine & International Health. 2 (9): 839–845. |
| [18] | Morris J, Stevens P (2006). Counterfeit Medicines in Less Developed Countries: Problems and Solutions. International Policy Network: London; 1-9. |
| [19] | World Health Organisation (WHO) (2007). Counterfeit medicines: an update on estimates. News Release WHO/7. 13 March 2007. Accessed on 21 August 2009 at http://www.istm.org/publications/ news_share/200805/counterfeit.aspx. |
| [20] | British Pharmacopoeia (2012). Vol II. British Pharmacopoeia Commission. The Stationery Office, London; 2293-2296. |
| [21] | United States Pharmacopoeia (2010). 33rd Revision. US Pharmacopoeial Convention, Rockville, MD. 3: 3870-3871. |
| [22] | Kumaraswamy G, Kumar JMR, Lakshmi SM. (2013). Validated spectroscopic method for estimation of frovatriptan succinate in bulk drug and pharmaceutical dosage form. Bulletin of Pharmaceutical and Medical Sciences (BOPAMS). Vol. 1. Issue. 1. |
| [23] | Okorie O, Omotoso A, Ebinyansi O (2016). Pharmaceutical Quality Analysis of Ceftriaxone Sodium Brands Marketed in Southern Nigeria. British Journal of Pharmaceutical Research. 9 (5): 1-8. |
| [24] | Allen LV, Popovich NG, Ansel HC (2012). Dosage form design: Pharmaceutical and formulation considerations. In: Ansel’s Pharmaceutical, Dosage Forms and Drug Delivery Systems. 9th Ed. Wolters Kluwer/Lippincott Williams & Wilkins. |
| [25] | Mubarak N, Nanda N, Anil Kumar KG, Perrett D, Tucker A, Johnston A (2012). The differences between the branded and generic medicines using solid dosage forms: In-vitro dissolution testing. Elsevier. 2: 1-8. |
| [26] | Oliveira EDFS (2009). Dissolution test optimization for meloxicam in the tablet pharmaceutical form. Brazilian Journal of Pharmaceutical Sciences. pp. 67-73. |
| [27] | Kassaye L, Genete G (2013). Evaluation and comparison of in-vitro dissolution profiles for different brands of amoxicillin capsules. Afr. Health Sci. 13 (2); 369-75. |
