Evaluation of the Pharmaceutical Characteristics of Various Enteric-Coated Aspirin Tablets under Different Storage Conditions

Abstract

The formulation characteristics of 6 brands of enteric-coated aspirin tablets under unpackaged conditions at 40°C and 60°C for 4 weeks were analyzed. Appearance, salicylic acid content, dissolution rates, and surface properties (by Raman microscopy) were evaluated to determine stability data, taking into account the clinical use of generic drugs. No change in appearance, decomposition, or dissolution rates was observed in unpackaged aspirin tablets stored at 40°C for 4 weeks. However, when stored at 60°C, tablets of 5 of the 6 brands showed whiskers on their surfaces along with an increase in salicylic acid content and a decrease in dissolution rate. Results of Raman mapping on the surface and cross sectional surface of the tablets with whiskers showed a salicylic acid peak associated with storage at 60°C for 4 weeks. However, for tablets from 1 of the 6 brands, no salicylic acid peaks were observed. For this tablet, Raman microscopy revealed 2 layers of film coating, and talc, which greatly affected the stability of the acetylsalicylic acid, was found only in the outer layer film. These results indicated that the protection of compatibility with talc is one of the important factors in enhancement of aspirin tablet stability in this tablet. We concluded that certification of the characteristics associated with stability and formulation is essential for generic drugs, which are not required to undergo stability testing under extreme storage conditions.

Performances of New Generation of Delayed Release Capsules

“…1 One justification for the use of enteric coating is to protect the stomach from an irritant drug as is the case with the non-steroidal anti-inflammatory drugs "NSAIDs" diclofenac sodium and aspirin. 2 Moreover, drugs that are degraded by the acidic pH of the stomach are protected by applying an enteric coat to the dosage form as with the proton pump inhibitor esomeprazole (e.g. Nexium ® , AstraZeneca).…”

Understanding the Roles of Excipients in Moisture Management in Solid Dosage Forms

“…Elongated particles near the clusters of ASA were observed after storage. These particles could be from crystallization of salicylic acid produced from ASA degradation . To quantify the extent of ASA degradation, the salicylic acid and ASA contents of the tablets were detected using HPLC.…”

A Prospective, Initiative, Single-Center Open Post-Registration Comparative Study of Laboratory Efficacy of Various Forms of Acetylsalicylic Acid in a Cardioprotective Dose with Different Composition of Excipients: Results of the SFAIROS Study

“…Дженерические препараты широко используются во многих странах мира, что оправдывается более низ- кой ценой по сравнению с оригинальными лекарственными средствами. Однако сохраняется обеспокоенность относительно применения таких средств изза отсутствия достаточной информации об их лабораторной и терапевтической эквивалентности [21,22]. Необходимость получения этой информации связана с тем, что при замене оригинального препарата на воспроизведенный необходимо быть уверенным в том, что больной получит лечение, которое будет характеризоваться сходной эффективностью.…”