Dissolution rates of various brands of proton pump inhibitors in combination with domperidone: an in vitro study
DOI:
https://doi.org/10.18203/2319-2003.ijbcp20233192Keywords:
Domperidone, Proton pump inhibitors, Omeprazole, EsomeprazoleAbstract
Background: Drug solubility, bioavailability, and dissolution rates are important in establishing in vivo efficacy. Eight brands of domperidone proton pump inhibitor combination drugs were compared to enable physicians to take an informed decision regarding the dissolution rates of various domperidone-PPI combinations available in the Indian market to allow identification and prescription of the drug with better bioavailability.
Methods: The in vitro dissolution rate of a combination of domperidone-PPI drugs was measured using the United States Pharmacopeia dissolution paddle apparatus. Each flask of the dissolving testing apparatus contained one tablet and 900 mL of the media, which was dissolved in pure water with 1% Tween® stored at 37.4°C. At regular intervals, aliquots were removed, filtered, and the amount of drug released was measured. The cumulative drug release was calculated using a standard formula.
Results: P04 and P07 had the fastest and the slowest onsets of action, respectively. P01 (Omez DSR) and P08 exhibited the longest and the shortest durations of action, respectively. The P05, P06, and P08 formulations had greater particulate matter than the other formulations. Under in vitro conditions, the bioavailability of Omez DSR was nearly two-fold higher than P07 and five-fold higher than P08.
Conclusions: Although P04 exhibited the fastest onset of action, Omez DSR had the longest duration of action, superior bioavailability, and ensured the rapid and continuous release of domperidone. Omez DSR demonstrated superior properties compared with other brands.
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References
Boulton KH, Dettmar PW. A narrative review of the prevalence of gastroesophageal reflux disease (GERD). Ann Esophagus. 2021;5:7.
Chowdhury SD, George G, Ramakrishna K, Ramadass B, Pugazhendhi S, Mechenro J, et al. Prevalence and factors associated with gastroesophageal reflux disease in southern India: A community-based study. Indian J Gastroenterol. 2019;38:77-82.
Srebro J, Brniak W, Mendyk A. Formulation of dosage forms with proton pump inhibitors: state of the art, challenges and future perspectives. Pharmaceutics. 2022;14(10):2043.
Saboo B, Mulwani N, Petare AU, Veligandhla KC, Pinto CS, Mane A, et al. A real-world retrospective study of omeprazole–domperidone combination in managing acid peptic disease with proton pump Inhibitors in patients with type 2 diabetes mellitus (PRIDE-2). Drugs Context. 2023;12:34-9.
Bhakta HC, Lin JM, Grover WH. Measuring dissolution profiles of single controlled release drug pellets. Sci Rep. 2020;10(1):19734.
Gul W, Sajid S, Hamid F, Bhatti S. Effect of acidic pH and heat on the degradation of omeprazole and esomeprazole. Pharma Innov J. 2015;4(8):19-21.
Jonaitis P, Jonaitis L, Kupcinskas J. Role of genetic polymorphisms of cytochrome P450 2C19 in pantoprazole metabolism and pantoprazole-based Helicobacter pylori eradication regimens. Curr Drug Metab. 2020;21(11):830-7.
Lee SH, Kim JE. Quality by design applied development of immediate-release rabeprazole sodium dry-coated tablet. Pharmaceutics. 2021;13(2):259.
Liu F, Shokrollahi H. In vitro dissolution of proton-pump inhibitor products intended for paediatric and geriatric use in physiological bicarbonate buffer. Int J Pharm. 2015;485(1-2):152-9.
Marakhouski KY, Karaseva GA, Ulasivich DN, Marakhouski Y Kh et al. Omeprazole-domperidone fixed dose combination vs omeprazole monotherapy: a phase 4, open-label, comparative, parallel randomized controlled study in mild to moderate gastroesophageal reflux disease. Clin Med Insights Gastroenterol. 2017; 10:1-8.
Wani P, McCallum RW, Bustamante-Bernal M. Domperidone: Everything a gastroenterologist needs to know. Pract Gastroenterol. 2015;17:16-39.
Enteshari S, Varshosaz J. Solubility enhancement of domperidone by solvent change in situ micronization technique. Adv Biomed Res. 2018;7:23-7.
Taghvaei T, Kazemi A, Hosseini V, Hamidian M, Fakheri HT, Hashemi SA, et al. Evaluation of the additive effect of domperidone on patients with refractory gastroesophageal reflux disease; A randomized double-blind clinical trial. Middle East J Dig Dis. 2019;11(1):24-31.
Generic drugs: Questions and answers. Available at: https://www.fda.gov/drugs/frequently-asked-questions-popular-topics/generic-drugs-questions-answers. Accessed on 20 April 2023.
Collins G, Ulman K, Muse DG, Zeleznik J, Zawislak P, Tocce E, et al. Additives and processing aids in pharmaceutical excipients. Pharm Technol. 2019; 2019(5):16-9.
Majumder T, Biswas GR, Majee SB. Hydroxy propyl methyl cellulose: Different aspects in drug delivery. J Pharm Pharmacol. 2016;4(8):381-5.
Rajbhar K, Jain Y, Barethiya V, Sahu S, Dixit GR. Dissolution-A quality parameter for testing of pharmaceutical dosage form. Int J Pharm Sci Rev Res. 2020;63(2):163-72.
Dizaj SM, Vazifehasl Z, Salatin S, Adibkia Kh, Javadzadeh Y. Nanosizing of drugs: Effect on dissolution rate. Res Pharm Sci. 2015;10(2):95-108.
Chishti MS, Ratna JV, Dar RA, Chisti S, Farooqui S. Consummated quantitative analysis of various generic brands of pantoprazole and domperidone in Srinagar division. Adv Pharm J. 2017;2(6):228-34.
Saha A, Jana M, Das A. Comparative in vitro evaluation of two commercially available brands of pantoprazole and domperidone capsules. Int Res J Pharm Sci. 2018;5(2):150-5.
Paul S, Bose A, Konar I, Pradip K. Comparative in vitro characterization of different commercially available brands of pantoprazole sodium tablets. World J Pharm Pharm Sci. 2017;6:778-83.
Jabbar L, Thiab A. Comparative study of in-vitro stability for the enteric coat of pellets of capsules of three different brands of omeprazole. Int J Res Pharm Sci. 2019;10(1):328-30.
Panakanti R, Narang AS. Impact of excipient interactions on drug bioavailability from solid dosage forms. In: Gupta RC, eds. Excipient Applications in Formulation Design and Drug Delivery. London, UK: Academic Press; 2015:273-310.
Quratulain SA, Muhammad HA, Javed W, Farooq O. Effectiveness, safety, and tolerability of esomeprazole and domperidone in gastroesophageal reflux Disease. Pak J Med Health Sci. 2022;16(08):781-3.
Strand DS, Kim D, Peura DA. 25 years of proton pump inhibitors: A comprehensive review. Gut Liver. 2017; 11(1):27-37
Ochoa D, Román M, Cabaleiro T, Saiz-Rodriguez M, Mejia G, Abad-Santos F. Effect of food on the pharmacokinetics of omeprazole, pantoprazole and rabeprazole. BMC Pharmacol Toxicol. 2014;2:78-82.
Chaturvedi S, Alim M, Agrawal VK. Solubility and dissolution enhancement of domperidone using 2-hydroxypropyl-β-cyclodextrin by kneading method. Asian J Pharm. 2017;11(03):476-81.
Van der Merwe J, Steenekamp J, Steyn D, Hamman J. The role of functional excipients in solid oral dosage forms to overcome poor drug dissolution and bioavailability. Pharmaceutics. 2020;12(5):393.
Patra CN, Priya R, Swain S, Jena GK, Panigrahi KC, Ghose D. Pharmaceutical significance of Eudragit: A review. Futur J Pharm Sci. 2017;3(1):33-45.
Kan SL, Lu J, Liu JP. Preparation and in vitro/in vivo evaluation of esomeprazole magnesium-modified release pellets. Drug Deliv. 2016;23(3):856-63.
Rao KS, Mishra VV, Nayak M. Pelletization technology in pharmaceutical formulation. Int J Adv Pharm Sci. 2019;1(2):1-10.
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