Interchangeability of medications and biopharmaceutical implication of taking drugs with fluids other than water
ibuprofen case study
DOI:
https://doi.org/10.1590/s2175-97902023e22725Keywords:
Ibuprofen, Dissolution test, Alcohol, Fruit juice, Tablets, CapsulesAbstract
The aim of this study was to compare the dissolution properties of ibuprofen solid oral dosage forms commercially available in Bosnia and Herzegovina and to estimate the influence of dissolution medium composition on the drug release. Eight products (A-H) were subjected to in vitro dissolution test using experimental conditions described in USP42-NF37. Dissolution properties of one selected product were examined in the presence of alcohol (22.2% v/v) and fruit juice (22.2% v/v). Products marked B-H complied with the pharmacopeial criteria. Dissolution profile of product B was similar with dissolution profiles of products D, E, F and G and similarity was also found between products A-D, C-G, D-G and E-F. Drug release from most of the examined preparations fitted best to the Weibull kinetic model. In the presence of alcohol in the medium, higher amount of ibuprofen was dissolved. Contrary, ibuprofen dissolved in the presence of fruit juice was significantly lower. Differences in the dissolution profiles of investigated preparations suggest that their interchangeability should be additionally considered and demonstrated with in vivo bioequivalence studies. Presence of different substances in the medium can affect dissolution properties of ibuprofen, emphasizing the importance of the patient’s compliance.
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Akdag Y, Gulsun T, Izat N, Oner L, Sahin S. Comparison of dissolution profiles and apparent permeabilities of commercially available metformin hydrochloride tablets in Turkey. Dissolution Technol. 2020;27(1):22-9.
ALIMS, 2022. Register of Medicinal Products of Bosnia and Herzegovina. Agency for Medicinal Products and Medical Devices of Bosnia and Herzegovina. 2022 Febrary, 2022 Febrary, http://www.almbih.gov.ba/_doc/registar2022/Registar2022.pdf (accessed 2022 July 20).
» http://www.almbih.gov.ba/_doc/registar2022/Registar2022.pdf
Almukainzi M, Alobaid R, Aldosary M, Aldalbahi Y, Bashiri M. Investigation of the effects of different beverages on the disintegration time of over-the-counter medications in Saudi Arabia. Saudi Pharm J. 2021;29(7): 699-705.
Bacchi S, Palumbo P, Sponta A, Coppolino MF. Clinical pharmacology of non-steroidal anti-inflammatory drugs: a review. Antiinflamm Antiallergy Agents. Med Chem. 2012;11(1):52-64.
Barron SE, Perry JR, Ferslew KE. The effect of ibuprofen on ethanol concentration and elimination rate. J Forensic Sci.1992;37(2):432-5.
Bertocchi P, Antoniella E, Valvo L, Alimonti S, Memoli A. Diclofenac sodium multisource prolonged release tablets-a comparative study on the dissolution profiles. J Pharm Biomed Anal. 2005;37(4):679-85.
Bjarnason I. Gastrointestinal safety of NSAIDs and over-the- counter analgesics. Int J Clin Pract Suppl. 2013;178:37-42.
Cardot J-M, Beyysac E, Alric M. In Vitro-In Vivo Correlation: Importance of dissolution in IVIVC. Dissolution Technol . 2007;14(1):15-9.
Deng J, Zhu X, Chen Z, Fan CH, Kwan HS, Wong CH, et al. A review of food-drug interactions on oral drug absorption. Drugs. 2017;77(17):1833-55.
Dressman J, Krämer J. Pharmaceutical dissolution testing. Boca Raton: Taylor & Francis; 2005.
Dutta M, Nath AK, Uddin MZ, Hossain M.A, Morshed MM, Kawsar MH. Effect of fruit juice on the dissolution of diclofenac sodium sustained release matrix tablets. IJPSR. 2011;2(12):3109-13.
Eraga SO, Arhewoh MI, Chibuogwu RN, Iwuagwu MA. A comparative UV− HPLC analysis of ten brands of ibuprofen tablets. Asian Pac J Trop Biomed. 2015;5(10):880-4.
Fagerberg JH, Al-Tikriti Y, Ragnarsson G, Bergström CA. Ethanol effects on apparent solubility of poorly soluble drugs in simulated intestinal fluid. Mol Pharm. 2012;9(7):1942-52.
FDA, 1997. Guidance for Industry: Dissolution Testing of Immediate Release Solid Oral Dosage Forms. Food and Drug Administation, Center for Drug Evaluation and Research (CDER), U.S. Department of Health and Human Services.
Fraser AG. Pharmacokinetic interactions between alcohol and other drugs. Clin Pharmacokinet. 1997;33(2):79-90.
Friuli V, Bruni G, Musitelli G, Conte U, Maggi L. Influence of dissolution media and presence of alcohol on the In vitro performance of pharmaceutical products containing an insoluble Drug. J Pharm Sci. 2018;107(1):507-11.
Gibson M, Pharmaceutical preformulation and formulation, 2nd ed. USA: IHS Health Group, 2009.
Hao H, Wang G, Sun J. Enantioselective pharmacokinetics of ibuprofen and involved mechanisms. Drug Metab Rev. 2005;37(1):215-34.
Hofmann M, García MA, Al-Gousous J, Ruiz-Picazo A, Thieringer F, Nguyen MA, et al. In vitro prediction of in vivo absorption of ibuprofen from suspensions through rational choice of dissolution conditions. Eur J Pharm Biopharm. 2020;149:229-37.
Hofsäss MA, Dressman JB. The discriminatory power of the BCS-Based biowaiver: A retrospective with focus on essential medicines. J Pharm Sci . 2019;108(9):2824-37.
Hom F, Veresh S, Miskel J. Soft gelatin capsules I: Factors affecting capsule shell dissolution rate. J Pharm Sci . 1973;62(6):1001-6.
Jaruratanasirikul S, Kleepkaew A. Influence of an acidic beverage (Coca-Cola) on the absorption of itraconazole. Eur J Clin Pharmacol. 1997;52(3):235-7.
Koziolek M, Alcaro S, Augustijns P, Basit AW, Grimm M, Hens B, et al. The mechanisms of pharmacokinetic food- drug interactions - A perspective from the UNGAP group. Eur J Pharm Sci . 2019;134:31-59.
Kubbinga M, Langguth P, Barends D. Risk analysis in bioequivalence and biowaiver decisions. Biopharm Drug Dispos. 2013;34(5):254-61.
Lee SL, Raw AS, Yu L. Dissolution testing. In: Krishna R, Yu L, editors. Biopharmaceutics applications in drug development. Boston, MA: Springer US; 2008. p. 47-74.
Lennernas H, Lindahl A, Van Peer A, Ollier C, Flanagan T, Lionberger R, et al. In vivo predictive dissolution (IPD) and biopharmaceutical modeling and simulation: future use of modern approaches and methodologies in a regulatory context. Mol Pharm aceutics. 2017;14(4):1307-14.
Lokhandwala H, Deshpande A, Deshpande E. Kinetic modeling and dissolution profile comparison: an overview. Int J Pharm Bio Sci. 2013;4(1):728-37.
Marchais H, Cayzeele G, Legendre JY, Skiba M, Arnaud P. Cross-linking of hard gelatin carbamazepine capsules: effect of dissolution conditions on in vitro drug release. Eur J Pharm Sci . 2003;19(2-3):129-32.
Martindale 39, 2017: The Complete Drug Reference. 39th edition. London: Pharmaceutical Press; 2017.
Medina JR, Salazar DK, Hurtado M, Cortés AR, Domínguez- Ramírez AM. Comparative in vitro dissolution study of carbamazepine immediate-release products using the USP paddles method and the flow-through cell system. Saudi Pharm J . 2014;22(2):141-7.
Minocha A, Barth JT, Herold DA, Gideon DA, Spyker DA. Modulation of ethanol-induced central nervous system depression by ibuprofen. Clin Pharmacol Ther. 1986;39(2):123-7.
Potthast H, Dressman JB, Junginger HE, Midha KK, Oeser H, Shah VP, et al. Biowaiver monographs for immediate release solid oral dosage forms: ibuprofen. J Pharm Sci . 2005;94(10):2121-31.
Rivera-Leyva JC, García-Flores M, Valladares-Méndez A, Orozco-Castellanos LM, Martínez-Alfaro M. Comparative studies on the dissolution profiles of oral ibuprofen suspension and commercial tablets using Biopharmaceutical Classification System criteria. Indian J Pharm Sci . 2012 Jul;74(4):312-8.
Shraim N, Hamawi T, Hummaid S, Adeli Ba, Radwan A, Shaikha F. Assessment of dissolution performance of immediate release ibuprofen products: Screening of products available on the Palestinian market. Palest Med Pharm J. 2018;3(1):31-8.
Simionato LD, Petrone L, Baldut M, Bonafede SL, Segall AI. Comparison between the dissolution profiles of nine meloxicam tablet brands commercially available in Buenos Aires, Argentina. Saudi Pharm J . 2018;26(4):578-84.
Singh S, Rao KR, Venugopal K, Manikandan R. Alteration in dissolution characteristics of gelatin-containing formulations. Pharmaceutical technology. 2002;26(4):36-54.
Soni T, Chotai N. Assessment of dissolution profile of marketed aceclofenac formulations. J Young Pharm. 2010;2(1):21-6.
Suarez-Sharp S, Li M, Duan J, Shah H, Seo P. Regulatory experience with In Vivo In Vitro correlations (IVIVC) in new drug applications. AAPS J. 2016;18(6):1379-90.
Tubic-Grozdanis M, Bolger MB, Langguth P. Application of gastrointestinal simulation for extensions for biowaivers of highly permeable compounds. AAPS J . 2008;10(1):213-26.
USP42-NF37, 2019. The United States Pharmacopeia 42, The National Formulary 37, The United States Pharmacopeial Convention, Rockville.
Wang Y, Snee RD, Keyvan G, Muzzio FJ. Statistical comparison of dissolution profiles. Drug Dev Ind Pharm. 2016;42(5):796-807.
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