Pharmaceutical technological evaluation of red yeast rice food supplements: Quality characteristics of tablets and capsules

Abstract

Abstract

Introduction : Red yeast rice (RYR)-containing food supplements (FSs) are widely used. However, considerable variability in their pharmaceutical-technological quality has been reported, highlighting the need for systematic evaluation. Aim : This study aimed to evaluate the pharmaceutical-technological characteristics of RYR-containing FSs and explore possible differences according to the declared formulation composition and dosage form. Materials and methods : A total of 15 commercially available FSs containing RYR were evaluated, including coated and uncoated tablets, as well as hard and soft gelatin capsules. Mass uniformity, mechanical strength, resistance to crushing, friability of uncoated tablets, and disintegration were evaluated according to the requirements of the European Pharmacopoeia (Ph. Eur.), 12 th edition. Results : The friability of all uncoated tablets was below 1%, with the lowest value being 0.12%. Mechanical strength ranged from 58.6 to 280 N. The sample with the highest mechanical strength also exhibited the lowest friability and the longest disintegration time. Disintegration times varied from 5 to 40 min and were generally shorter for capsules than for tablets. Two hard gelatin capsule samples failed the mass uniformity test, whereas all four uncoated tablet samples exceeded the pharmacopeial disintegration limits. Discussion : The observed differences may reflect variations in formulation composition and excipient content. Microcrystalline cellulose, polyvinylpyrrolidone, and hypromellose may contribute to mechanical resistance, whereas starch and croscarmellose may promote disintegration. Lipophilic components and plant extracts may also affect dosage-form properties. Conclusion : Some RYR-containing FSs complied with all applicable Ph. Eur. requirements, whereas others showed deviations in mass uniformity or disintegration. The findings demonstrate variability among commercially available products and support the need for systematic pharmaceutical-technological quality assessment.