Investigation of the effects of different beverages on the disintegration time of over-the-counter medications in Saudi Arabia

Saudi Pharm J. 2021 Jul;29(7):699-705. doi: 10.1016/j.jsps.2021.04.032. Epub 2021 May 8.

Abstract

Full disintegration of Oral solid dosage forms is critically important to achieve reliable clinical performance of the drug. Tablets/capsules are supposed to be taken with a full glass of water; however, many patients do not follow this recommendation as they administer their medications with beverages other than water. This study aims to assess the impact of different commonly consumed beverages in Saudi Arabia on the disintegration times of common over-the-counter (OTC) medication tablets and capsules in the Kingdom of Saudi Arabia. Five immediate release OTC drugs were chosen: Fevadol®, Solpadeine®, Ralaxon®, Artiz ®, and Brufen®. The disintegration times of these medications were assessed using a disintegration test in five beverages: Coca-cola, arabic coffee, orange juice, buttermilk and an energy drink. Times were compared to the disintegration time in water under two temperature conditions (37 °C and 5 °C). All beverages significantly increased the disintegration times of fevadol, solpadeine, and relaxon in comparison with water. The same was found for burfen, except that arabic coffee did not significantly increase disintegration time (p > 0.05). The disintegration time of artiz tablets was also significantly influenced by all beverages, except for Coca-cola and the energy drink, which had no significant impact on the disintegration time. The tested beverages should not be used as substitutes for water when ingesting medications. Patients should be advised to avoid consuming beverages other than water with therapeutic products. Increasing public awareness of drug-beverage interactions is needed.

Keywords: BCS, Biopharmaceutics classification system; Beverages; Compendial disintegration test; DT, Disintegration time; IR, Immediate release; Immediate release; OSDF; OSDFs, Oral solid dosage forms; OTC; OTC, Over the counter; QC, Quality control; QbD, Quality by design; SD, Standard deviation; Spss, Statistical Package for the Social Sciences; USP, United States Pharmacopeia.