Marta Slavkova, Teodora Popova, Christina Voycheva, Stanislav Bozhanov, Vania Maslarska, Milen Dimitrov
Marta Slavkova1, Teodora Popova1, Christina Voycheva1, Stanislav Bozhanov2*, Vania Maslarska2, Milen Dimitrov1
1Department of Pharmaceutical Technology and BioPharmacy, Faculty of Pharmacy, Medical University – Sofia, 2 Dunav str., Sofia 1000, Bulgaria.
2Department of Chemistry, Faculty of Pharmacy, Medical University-Sofia, 2 Dunav Str., Sofia 1000, Bulgaria.
Volume - 14,
Issue - 12,
Year - 2021
The need for additional fluids for easy absorption is typical for elderly patients and those with dysphagia. Most often, these patients take their medication with a glass of orange juice or another liquid instead of a glass of water. We conducted a dissolution test with gastro-resistant tablets acetylsalicylic acid where different kind of orange juice or soft drink w?re added to the release medium. As a control, release medium - buffers 1.2, 4.5 and 6.8 were used. The released aspirin was determined after HPLC analysis. The obtained data were fitted to different kinetic models. The results of the dissolution test in medium buffers with added different beverage showed results similar to those obtained in pure buffer, where it is used an artificial sweetener and different, when sugar or glucose-fructose syrup was used to sweeten the beverage. The most significant change was observed in the release kinetics of the active substance.To exclude the possibility that the other beverage ingredients or excipients used to make the tablets affect the release profile of acetylsalicylic acid, we conducted a beverage-like dissolution test. Instead of a original beverage, we used water and sugar syrup, in a concentration that is declared on the label of the original beverages. The results obtained confirm that different sugar concentrations alter the release profile of acetylsalicylic acid from gastro resistant tablets when they are taken with a glass of sugar-containing beverage instead of a glass of water.
Cite this article:
Marta Slavkova, Teodora Popova, Christina Voycheva, Stanislav Bozhanov, Vania Maslarska, Milen Dimitrov. Effect of soft beverages on the in vitro dissolution of gastro-resistant tablets containing low dose Acetylsalicylic acid. Research Journal of Pharmacy and Technology. 2021; 14(12):6345-2. doi: 10.52711/0974-360X.2021.01097
Marta Slavkova, Teodora Popova, Christina Voycheva, Stanislav Bozhanov, Vania Maslarska, Milen Dimitrov. Effect of soft beverages on the in vitro dissolution of gastro-resistant tablets containing low dose Acetylsalicylic acid. Research Journal of Pharmacy and Technology. 2021; 14(12):6345-2. doi: 10.52711/0974-360X.2021.01097 Available on: https://www.rjptonline.org/AbstractView.aspx?PID=2021-14-12-27
1. Fuchs J. The amount of liquid patients use to take tablets or capsules. Pharmacy Practice. 2009; 7(3): 170-174.
2. Varum FJO, Hatton GB, Basit AW. Food, physiology and drug delivery International Journal of Pharmaceutics. 2013; 457: 446–460.
3. Asif F, Sultana T, Sohel1 D, Sumon MHU, Kawsar H, Islam A. In vitro dissolution pattern of metronidazole film coated tablet in presence of fruit juice. American Journal of Pharmacological Sciences. 2014; 2(2): 32-36.
4. Greenblatt DJ. Analysis of drug interactions involving fruit beverages and organic anion-transporting polypeptides. The Journal of Clinical Pharmacology. 2009; 49: 1403–1407.
5. Wason S, DiGiacinto JL, Davis MW. Effects of grapefruit and seville orange juices on the pharmacokinetic properties of colchicine in healthy subjects. Clinical Therapeutics. 2012; 34(10): 2161–2173.
6. Chillistone S, Hardman J. Factors affecting drug absorption and distribution. Anaesthesia and Intensive Care Medicine. 2014; 15(7): 309-313.
7. Bailey DG, Spence JD, Munoz C, Arnold JM. Interaction of citrus juices with felodipine and nifedipine. The Lancet. 1991; 337(8736): 268–269.
8. Messer A, Raquet N, Lohr C, Schrenk D. Major furocoumarins in grapefruit juice II: Phototoxicity, photogenotoxicity, and inhibitory potency vs. cytochrome P450 3A4 activity. Food and Chemical Toxicology. 2012; 50(3-4): 756–760.
9. Chuong MC, Taglieri CA, Crosby SJ, Ferullo JW, Ng P. Effect of beverages on the in vitro disintegration of immediate-release pain medications. Dissolution Technologies. 2010; 17(1): 31-37.
10. Feldman M, Barnett C. Fasting gastric pH and its relationship to true hypochlorhydria in humans. Digestive Diseases and Sciences. 1991; 36(7): 866-869.
11. Evans DF, Pye G, Bramley R, Clark AG, Dyson TJ, Hardcastle JD. Measurement of gastrointestinal pH profiles in normal ambulant human subjects. Gut. 1988; 29: 1035–1041.
12. Charman W, Porter C, Mithan S, Drerssman J. Physicochemical and physiological mechanisms for the effects of food on drug absorption: The role of lipids and pH. Journal of Pharmaceutical Sciences. 1997; 86(3): 269-282.
13. British Soft drink Association, The 2013 UK Soft Drinks Report, British soft drink association, London, UK, https://www.britishsoftdrinks.com/write/MediaUploads/Publications/2013UKsoftdrinksreport.pdf
14. British Soft drink Association, The 2019 UK Soft Drinks Report, British soft drink association, London, UK, https://www.britishsoftdrinks.com/write/MediaUploads/BSDA_Annual_Report_2019.pdf
15. Stegemann S, Gosch M, Breitkreutz J. Swallowing dysfunction and dysphagia is an unrecognized challenge for oral drug therapy. International Journal of Pharmaceutics. 2012; 430(1–2): 197–206.
16. Kostewicz ES, Abrahamsson B, Marcus B, Brouwers J, Butler J, Carlert S, Dickinson PA, Dressmana J, Holmg R, Kleinh S, Manni J, McAllister M, Minekus M, Muenster U, Müllertz A, Verwei M, Vertzoni M, Weitschies W, Augustijns P. In vitro models for the prediction of in vivo performance of oral dosage forms. European Journal of Pharmaceutical Sciences. 2014; 57: 342–366.
17. Koziolek M, Görke K, Neumann M, Garbacz G, Weitschies W. Development of a bio-relevant dissolution test device simulating mechanical aspects present in the fed stomach. European Journal of Pharmaceutical Sciences. 2014; 57: 250–256.
18. Pant S, Pal K. Development and validation of a simultaneous HPLC method for assay and dissolution of bisoprolol fumarate and amlodipine besylate in pharmaceutical dosage. Research Journal of Pharmaceutical Dosage Forms and Technology. 2012; 4(1): 62-66.
19. Kasad PA, Muralikrishna KS. Design and validation of dissolution profile of rivaroxaban by using RP-HPLC method in dosage form. Asian Journal of Pharmaceutical Analysis. 2013; 3(3): 75-78.
20. Dhingra G, Sreelesh B, Nagpal M, Rakha P, Nagori BP. In-vitro dissolution testing of ibuprofen using compendial and biorelevant dissolution media. Research Journal of Pharmacy and Technology. 2010; 3(3): 931-933.
21. Kumaraswamy G, Ravindra N, Jyothsna B. development and validation of a reversed-phase HPLC method for simultaneous determination of aspirin, atenolol and amlodipine in capsules dosage forms. Asian Journal of Pharmaceutical Analysis. 2014; 4(3): 116-120.
22. Ismail RR, Ganesh M, Jagadeeswaran M, Srinivasan K, Valarmathi J, Sivakumar T. RP-HPLC method for the simultaneous determination of aspirin, atorvastatin and pioglitazone in capsule dosage form. Asian Journal of Research in Chemistry. 2008 1(1): 40-42.
23. Nanda RK, Potawale SE, Bhagwat VV, Hamane SC, Deshmukh RS. Development and validation of a HPLC method for simultaneous analysis of aspirin and atorvastatin calcium as the bulk drugs and in the capsule dosage form. Asian Journal of Research in Chemistry. 2010; 3(4): 961-964.
24. Godge RK, Shinde GS, Joshi S. Simultaneous estimation and validation of dapagliflozin and saxagliptin in bulk drug and dosage form by RP-HPLC. Research Journal of Science and Technology. 2019; 11(1): 59-63.
25. Anees A, Bahazeq AA, Muzaffar-Ur-Rehman MD, Akbar S, Mehveen J. Development and validation of memantine hydrochloride by RP-HPLC method. Asian Journal of Pharmaceutical Research. 2019; 9(2): 69-74.
26. Naik AR, Ajay KD, Venkatesh M. Method development and validation of taurine and acetyl cysteine by using RP -HPLC method. Asian Journal of Research in Pharmaceutical Sciences. 2018; 8(4): 223-235.
27. Rana MA, Raj HA. Development and validation of high performance liquid chromatography method for levosulpiride and its intermediate in synthetic mixture. Asian Journal of Pharmacy and Technology. 2015; 5(2): 97-106.
28. World Helath Organisation, The Top 10 Causes of Death, May 2018, https://www.who.int/news-room/fact-sheets/detail/the-top-10-causes-of-death
29. World Health Organization, 2007. Prevention of Cardiovascular Disease. Guidelines for assessment and management of cardiovascular risk, WHO Press, Geneva, Switzerland
30. Golan D, Tashjian AH, Armstrong EJ, Armstrong AW. Principles of pharmacology: the pathophysiologic basis of drug therapy. Lippincott Williams & Wilkins, Philadelphia. 2012; 3rd ed:pp. 755-756.
31. Loll PJ, Picot D, Garavito RM. The structural basis of aspirin activity inferred from the crystal structure of inactivated prostaglandin H2 synthase. Nature Structural Biology. 1995; 2: 637–643.
32. Blobaum A, Marnett LJ. Structural and functional basis of cyclooxygenase inhibition, Journal of Medicinal Chemistry. 2007; 50(7): 1425-1441.
33. Santilli F, Rocca B, Cristofaro R, Lattanzio S, Pietrangelo L, Habib A, Pettinella C, Recchiuti A, Ferrante E, Ciabattoni G, Davì G, Patrono C. Platelet cyclooxygenase inhibition by low-dose aspirin is not reflected consistently by platelet function assays: implications for aspirin “resistance”. Journal of the American College of Cardiology. 2009; 53 (8): 667–677.
34. Petri MH, Tellier C, Michiels C, Ellertsen I, Dogné J, Bäck M. Effects of the dual TP receptor antagonist and thromboxane synthase inhibitor EV-077 on human endothelial and vascular smooth muscle cells. Biochemical and Biophysical Research Communications. 2013; 441(2): 393–398.
35. Baigent C, Blackwell L, Collins R, Emberson J, Godwin J, Peto R, Burinq J, Hennekens C, Kearney P, Meade T, Patrono C, Roncaqlioni MC, Zanchetti A. Aspirin in the primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data from randomised trials. The Lancet. 2009; 373(9678): 1849–1860.
36. Braunwald E, Antman EM, Beasley JW,. Califf RM, CheitlinMD, Hochman JS, Jones RH, Kereiakes D, Kupersmith J, Levin TN, Pepine CJ, Schaeffer JW, Smith EE, Steward DE, Theroux P, Gibbons RJ, Alpert JS, Eagle KA, Faxon DP, Fuster V, Gardner TJ, Gregoratos G, Russell RO, Smith SC. ACC/AHA guidelines for the management of patients with unstable angina and non–ST-segment elevation myocardial infarction: Executive summary and recommendations. Circulation. 2000; 102(10): 1193–1209.
37. Bertrand ME, Simoons ML, Fox KA, Wallentin LC, Hamm CW, McFadden E, De Feyter J, Specchia G, Ruzyllo W. Management of acute coronary syndromes: Acute coronary syndromes without persistent st-segment elevation; recommendations of the task force of the European society of cardiology. European Heart Journal. 2000; 21(17): 1406–1432.
38. Patrono C, Baigent C, Hirsh J, Roth G. Antiplatelet drugs: American College of Chest Physicians evidence-based clinical practice guidelines (8th ed.). Chest. 2008; 133(6 Suppl): 199S–233S.
39. Patrono C, Coller B, FitzGerald GA, Hirsh J, Roth G. Platelet-active drugs: the relationships among dose, effectiveness, and side effects: the seventh ACCP conference on antithrombotic and thrombolytic therapy. Chest. 2004; 126(3 Suppl): 234S-264S.
40. Gilpin VL. Review of an article: Aspirin for primary prevention of cardiovascular events in people with diabetes. (2010). A position statement of the American Diabetes Association (ADA), a scientific statement of the American Heart Association (AHA), and an expert consensus document of the American College of Cardiology Foundation (ACCF). Diabetes Care, 33:6; June 2010; 1395-1402. Journal of Vascular Nursing. 2010; 28(4): 154- 155.
41. Meek IL, Van de Laar MAFJ, Vonkeman HE. Non-steroidal anti-inflammatory drugs: an overview of cardiovascular risks. Pharmaceuticals, 2010; 3: 2146-2162.
42. Eccles M, Freemantle N, Mason J. North of England evidence based guideline development project: guideline on the use of aspirin as secondary prophylaxis for vascular disease in primary care. The British Medical Journal. 1998; 316(7140): 1303–1309.
43. Conthe P, Contreras EM, Pérez AA, García BB, Martín MNF, Jurado MG, Baturone MO, Pinto JL. Treatment compliance in chronic illness: Current situation and future perspective. Revista Clínica Española. 2014; 214(6): 336-344.
44. Garcia-Hernandez A. Quality-of-life-adjusted hazard of death: a formulation of the quality-adjusted life-years model of use in benefit-risk assessment. Value in Health. 2014; 17: 275-279.