Lebanon is one of the Mediterranean countries that are devastated by economic crisis. Knowing that generic medications are less costly when compared to brands, it is crucial to assess patients’ understanding and views regarding these medications.
A 25-item self-administered anonymous questionnaire was distributed to a total of 421 participants. The questionnaire appraised participants’ knowledge and perceptions about generics versus brand medications, in addition to their perceptions and attitudes towards generic substitution. Most respondents agreed that generics are not inferior to their brand equivalents in terms of quality, efficacy and safety (66%, 68.9%, and 66.7%, respectively). On the other hand, 79.4% (n=334) accepted generic substitution for minor ailment medications, whereas, only 56.1% (n=236) accepted this substitution for their chronic medications. As a conclusion, the uncertainty about the use of generic medications, particularly those treating chronic illness is still an obstacle to overcome.
Novel and accurate analytical methods were developed and validated for the characterization of Fluoxetine in its pure and pharmaceutical dosage form Prozac®. Fluoxetine was determined by IBA techniques (PIGE, PIXE and RBS). It has been also analyzed spectrophotometrically at 610 nm after oxidation with potassium permanganate in alkaline medium. In addition, Fluoxetine was kinetically determined using the initial rate method, the fixed absorbance method and the fixed time method. Moreover, a Gas chromatography - mass spectrometry technique is proposed for the investigation of Fluoxetine without a prederivatization phase. The spectrophotometric method was performed with a concentration array of 2-10 μg/mL at 610 nm and a regression coefficient (r) of 0.996. The fixed time method was the most suitable one to determine Fluoxetine with correlation coefficient value (r) of 0.9966. The Gas chromatography - mass spectrometry investigated the drug in a concentration range of 20-100 μg/mL and a regression coefficient (r) of 0.999. IBA analysis presented a precision of less than 3% and a very low limit of detection. Consequently, these proposed methods would be useful tools for determining Fluoxetine as all the assay results exposed satisfactory sensitivity, accuracy and reproducibility
Drugs with narrow therapeutic index (NTI-drugs) have been defined by the FDA as drugs with small differences between therapeutic and toxic doses that might lead to serious therapeutic failures or life-threatening adverse drug reactions. Levothyroxine sodium pentahydrate (LT4), a synthetic T4 hormone used for the treatment of hypothyroidism (a condition where there is a hormonal imbalance in the thyroid gland that is responsible for the regulation of several physiological, metabolic, cardiovascular, and neurological processes). LT4 is designated by the FDA as a narrow therapeutic index drug and is available in the market in the form of very low dose pharmaceutical formulations ranging from 25 mcg to 150 mcg. This requires that the pharmaceutical dosage form should contain the exact labeled amount of the active ingredient, LT4, such that safety and efficacy are maintained. Therefore, it is necessary to develop an a precise, accurate and sensitive analytical method for LT4 quantification considering the treatment doses being in micrograms. In the present work, an ion exchange HPLC method has been developed and validated for the determination of LT4 as per ICH guidelines. The developed method was found to be simple, sepcific, precise and accurate. The low LOD and LOQ values allowed the quantitfication of the active ingredient in different pharmaceutical products qualifying the method to be applied in quality control assays.
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