Bioequivalence studies are expensive, time consuming and invasive to humans. Accordingly, an alternative in vitro study (biowaivers) has been introduced for drugs which belong to BCS class I and III and for other strengths of already approved higher drug strength. The main objective of this study was to prove the biowaiver eligibility of a lower strength Ramipril/Hydrochlorothiazide (2.5/12.5 mg) tablets. Visual and pharmacopoeial quality tests were performed on the higher and lower generic and on the reference listed drug to determine whether they are pharmaceutically equivalent. All products were investigated using the biowaiver criteria. Dissolution profiles were conducted at pH values 1.2, 4.5 and 6.8. Difference factor () and similarity factor () were calculated. The tested products were successfully complied with pharmacopeial requirements. was below 15 and was above 50 in all dissolution conditions. Precisely, Ramipril showed release higher than 85% within 15 min. and for Hydrochlorothiazide were 8 and 61 respectively at the recommended discriminative pH media.These results suggest that the current biowaiver criteria could be a sufficient guarantee of bioequivalence of the lower strength of Ramizide assuming that the product is manufactured at the same site and contains same quality and grade of excipients and in a proportional amounts.

BackgroundElectronic tongue (ET) is a well-established technology that is used to detect the taste of a food or a medicinal product and to differentiate between different products based on their tastes. In addition, it can be used to monitor environmental parameters and biochemical and biological processes.PurposeThis study aims to assess any correlation between the results of pharmacopeial quality control (ie, assay, impurities, and dissolution, etc) and ET analysis for reconstituted cefdinir (CR) suspension over 10 days (ie, shelf-life).MethodsThe reconstituted CR suspension was tested for several quality attributes such as dissolution behavior, pH, assay, related substances, and microbial contamination. An HPLC analytical method was verified and then used for chemical analysis. The taste of CR reconstituted suspension was followed over 10 days and was then compared with the quality control results. Moreover, Pearson’s correlation test was used to find a correlation between chemical analysis results and ET results.ResultsPearson’s test of correlation showed a significant correlation (p-value <0.05) between the conventional chemical analysis results (% of CR, % of preservative, % of released CR, % of total impurities and % of total undefined impurities in the reconstituted suspension) with the change of their taste (ie, % pattern discrimination index). ET was able to correlate the results of stability of CR suspension with the change in the taste of the suspension during the shelf life of the reconstituted suspension.ConclusionThe obtained results may suggest the use of ET as a new tool for a rapid assessment of the general quality of a suspension. Moreover, such results would suggest the use of ET to identify fake or substandard products, especially those have been stored under inappropriate storage conditions.

A new HPLC method that is based on zwitterionic hydrophilic interaction liquid chromatography (ZIC-HILIC) coupled with ultraviolet detection was developed, optimized and validated for the simultaneous determination of amprolium hydrochloride, sulfaquinoxaline sodium, and Vitamin K 3 (as menadione sodium bisulfite) in A.S.K powder. The separation was carried out using ZIC-HILIC column (250 mm × 4.6 mm, 5 mm) and a mobile phase of 0.2 M Ammonium acetate (NH 4 AC) buffer and acetonitrile (15:85; v/v) with pH adjusted to 5.7 by glacial acetic acid at a flow rate of 0.5 ml/min. The analytes were monitored by UV detection at 263 nm.

Dissolution profiles were developed in three different pH media for the evaluation of valsartan/amlodipine (VS/AM) release from tablets. The selection of the most appropriate dissolution method was based on the calculated similarity (f 2 ) and dissimilarity (f 1 ) values. A new HPLC method was developed to quantify VS/AM in tablets. The method was validated in accordance with international guidelines and showed acceptable linearity, accuracy, precision, and selectivity. The system suitability results are within the acceptance criteria. The dissolution method (pH 6.8 phosphate buffer) was selected because it showed the highest f 2 and the lowest f 1 values for VS and AM among the other tested dissolution media. This method could be used for in vitro quality control and for performing in vitro-in vivo correlation (IVIVC) during the development of new generic tablets.

The patient package inserts (PPIs) should contain all the required information for the patient. It must be clear and understandable. There are several problems with the PPIs including the wrong information, readability and comprehensibility. Thus the pharmacists have to take an active role in making sure that patient is aware of important instruction including correct storage. Five antibiotics namely Erythromycin ethylsuccinate, Amoxicillin, Cefdinir, Flucloxacillin sodium and Clarithromycin powder for suspensions, were selected for this study, these antibiotic were reconstituted as directed on the label and tested initially and after 7 days when stored at room temperature and in refrigerator. Several chemical and physical pharmacopeial tests were performed. The results showed that two of the antibiotic oral suspensions namely erythromycin ethyl succinate and flucloxacillin sodium failed the accepted shelf life specification limits when stored at room temperature while both passes these limits when stored in refrigerator. Erythromycin ethylsuccinate has failed the tests of taste and odour while the flucloxacillin sodium has failed the assay test. Clarithromycin has failed some tests as viscosity, taste and pouring test when stored in refrigerator while passes all the tests when stored at room temperature. The study showed the vital role of the pharmacist to reiterate the important patient package insert instructions specially those concerned with the storage condition of the drug.