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Lamivudine is one of the most prescribed drugs in the world, and is used to treat human immunodeficiency and hepatitis B. This study aimed to evaluate the quality attributes and compare the dissolution profiles of two batches (A and B) of generic lamivudine 150 mg tablets with the innovator drug Epivir 150 mg tablets. We conducted an analytical, experimental, cross-sectional study, and used a spectrophotometric method at a wavelength of maximum absorption (λ) corresponding to 270 nm, to measure the percentage of dissolved drug. The study evaluated identification, content, dissolution and mass uniformity. Apparatus 2 USP (Paddle) 75 rpm, 900 mL of dissolution medium (37 ± 0.5 °C) was used in three dissolution media: pH 1.2; 4.5 and 6.8. Samples of 5 mL were obtained at 5, 10, 15, 20 and 30 min. Both batches of generic lamivudine (A and B) were found to have the same dissolution kinetic profile as the innovator drug. Both formulations met the criteria of very fast dissolving (85% dissolved in 15 min), and fast dissolving (85% dissolved in 30 min) drugs. Therefore, it was not necessary to calculate the similarity factor. We concluded that generic drugs A and B are in vitro equivalents to the innovator drug Epivir. [ABSTRACT FROM AUTHOR]

The medicines’ interchangeability represents a necessity in developing countries, because it offers the possibility of accessing lower cost products, it allows to ensure efficacy and safety in pharmacotherapeutic treatments. The study gather researches carried out in the Peruvian state published in high-impact databases such as Scielo, Sciencedirect, Scopus and Pubmed. Of the 553 researches found, only 10 articles met the inclusion and exclusion criteria, drugs such as diazepam, prednisone, amoxicillin, doxycycline, fluconazole, phenytoin sodium, alprazolam, amlodipine, carbamazepine sodium, glibenclamide, moxifloxacin and acetylsalicylic acid were identified. All the articles analyzed the dissolution profile by calculating the similarity factor f2, while, in other cases, they estimated parameters such as weight variation, friability, hardness, quantification, content uniformity, and dissolution profile. The results show that 9 drugs included in the study were analyzed by in vitro studies at different pH (1.2; 4.5 and 6.8), and complied with presenting a similarity factor f2 greater than 50. It is concluded that, the interchangeability of medicines in the Peruvian state is still in process, and that, through strategic alliances with the private sector, a greater number of pharmaceutical alternatives could be had in the patient's recovery. [ABSTRACT FROM AUTHOR]

Introduction: The pharmaceutical industry seeking approval to market a generic drug must submit data demonstrating that the generic formulation provides the same quality, efficacy, and safety of the innovative drug. Therefore, most orally administered generic drugs are approved based on the results of one or more physicochemical and biopharmaceutical studies to demonstrate bioequivalence and subsequent interchangeability. Objective: Identify in research articles the possible differences between the physicochemical and biopharmaceutical tests of bioequivalence of generic drugs with that of their corresponding innovative equivalents. Method: The original research studies, published from January 2003 to December 2019, were reviewed. 4 databases were consulted Pubmed, ScienceDirect, Lilacs, Scielo. In English and Spanish. The descriptors used were generic medicine, bioequivalence, therapeutic equivalence and interchangeability, likewise only those articles where their study pharmaceutical form was tablets were selected. Results: A total of 40 articles were selected for evaluation, of which 19 reached the conclusion of bioequivalence, another 19 determined non-bioequivalence, for 1 there was no definitive conclusion, while in a study that evaluated 3 drugs, the conclusion was no bioequivalence for 2 of them and bioequivalence for one. Conclusions: The review reveals that the studies are insufficient to indicate bioequivalence between multi-source (generic) and innovative drugs, so that bioequivalence studies need to be expanded. [ABSTRACT FROM AUTHOR]

Generic drugs play an important role in healthcare systems as they represent an effective and more affordable alternative for the population. In Peru, a regulation of interchangeability of generic drugs (also called multisource drugs) was stablished to define the procedures and requirements for developing in vivo and in vitro therapeutic equivalence studies, following the gradual application approach and sanitary risk criteria. Compliance with the new regulation will allow greater access to effective, safe and quality generic drugs. Meanwhile, drugs continue to be marketed in the absence of therapeutic equivalence studies. Findings show that some drugs failed in in vivo and in vitro comparisons with the reference product. This regulation represents a great challenge for manufacturers and holders of sanitary registrations in order to demonstrate the interchangeability of their pharmaceutical products with the reference product. [ABSTRACT FROM AUTHOR]

The aim of this study was to assess therapeutic equivalence through in vitro studies of four different brands of pharmaceutical products containing amoxicillin, doxycycline and fluconazole purchased in pharmacies from metropolitan Lima, establishing their interchangeability with a reference product (RP). A validated method of ultraviolet -- visible spectrophotometry was used to determine the dissolution profile. The similarity factor (f2) was used to establish therapeutic equivalence evaluated by in vitro studies, considering two formulations as equivalents if the values were within 50 and 100. The four brands of doxycycline studied were equivalents in vitro to RP. Only two of the four brands of Amoxicillin were equivalent in vitro to RP and none of Fluconazole brands were equivalent in vitro to PR. Therefore, there are some pharmaceutical products containing amoxicillin and fluconazole which are available in the national market and do not meet with therapeutic equivalence evaluated by in vitro studies, in other words, they are not interchangeable. [ABSTRACT FROM AUTHOR]

Physicians should always remember that a negative result in a superiority trial never would prove that the therapies under research are equivalent; more often, there may be a risk of type 2 (false negative) error. Equivalence and not inferiority studies demand high standards to provide reliable results. Physicians should take into account above all that the equivalence margins tend to be too large to be clinically significant and that the claim of equivalence can be misleading if a study has not been conducted at a sufficiently high level. In addition, physicians must be a bit skeptical of judgments that do not include the basic requirements of information, including the definition and justification of the equivalence margin, the calculation of the size of the sample bearing in mind this margin, the presentation of both analysis (intention-to-treat and by protocol), and provide confidence intervals for the results. Equivalence and inferiority studies are not indicated in certain areas. If one follows the required strict adherence to the specific methodology, such studies can provide new and important knowledge. [ABSTRACT FROM AUTHOR]

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Objective: Comparison of the bioequivalence of three pharmaceutical formulations of fluticasone propionate nasal administered with a nasal spray (FANS). Materials y Methods: A randomized, open-label, single-dose, three-way crossover study in 60 healthy volunteers of both sexes between 18 and 55 years old. Subjects received a single intranasal dose (800 mcg) of FANS, Flonase®, and Flixonase® in 5 visits: screening, 3 dosing visits, and end of study. Forty-eight hours to 7 days were allowed between dosing visits. Blood was drawn for pharmacokinetics analysis at appropriate intervals. The primary pharmacokinetic parameter for determination of bioequivalence of the formulations was the area under the plasma concentration-time curve (AUC0-t). Secondary parameters included the maximum plasma concentration (Cmax). FANS was compared to Flonase® and to Flixonase® separately. Results: Bioequivalence between FANS and Flonase® (n=55) was demonstrated by the inverse log transformed AUC0-t (ratio FANS to Flonase® = 1.021; 90%CI, 0.88 to 1.19), and Cmax, (ratio = 0.995; 90% CI, 0.92 to 1.07), which are within the acceptable range of 0.80 to 1.25. Bioequivalence between FANS and Flixonase® (n=54) was also demonstrated for AUC0-t (ratio = 0.949; 90%CI 0.81 to 1.10) and Cmax (ratio = 0.939, 90% CI, 0.87 to 1.02). Active treatments were well tolerated and there were relatively few adverse events. Conclusions: A single dose of FANS 800 mcg is pharmacokinetically bioequivalent to both Flonase® and Flixonase® when administered to healthy subjects. The safety profile of FANS was consistent with that noted for Flonase® and Flixonase®. [ABSTRACT FROM AUTHOR]

Objective. The primary objective of this study was to establish the clinic equivalence of a new Fluticasone Propionate Aqueous Nasal Spray (FANS) compared to two commercially available active treatments of fluticasone propionate nasal spray (Flonase® and Flixonase®) during the mountain cedar (Juniperus ashei) pollen season in Texas. Material and methods. This was a multicenter, randomized, double-blind, double-dummy, active-controlled and placebo-controlled, parallel group study designed to investigate the safety and efficacy of FANS (200 mcg QD), Flonase® and Flixonase® (200 mcg QD) compared to placebo administered for 13 to 15 days. Patients recorded the total nasal symptoms dcores (TNSS) in a diary in the morning and evening every day. The primary endpoint was the patient-rated am and pm TNSS +1. Other key efficacy endpoints were patient-rated AM TNSS+1, patient-rated PM TNSS+1, and safety. Results. Mean TNSS values for Flonase® and Flixonase® were not statistically significantly different from FANS during any study day, over the entire treatment period, or at endpoint. Bioequivalence between FANS and Flonase® (ratio= 0.98, 90% CI 0.91 to 1.06) as well as FANS and Flixonase® (ratio=1.02, 90% CI 0.94 to 1.10) was demonstrated for the primary endpoint [Patient-Rated am and pm TNSS +1] as well as for the other key efficacy endpoints. Conclusions. The findings from this study support that FANS 200 mcg QD is therapeutically bioequivalent to both Flonase® and Flixonase® in the control of the symptoms of seasonal allergic rhinitis. [ABSTRACT FROM AUTHOR]

A generic medicine is a pharmaceutical product containing an active ingredient already known and previously developed and invented by others. The cost of these generic or multisource products should be less than their counterparts original. The clinical effects and the risk-benefit balance of a medicine do not depend exclusively on the activity of a pharmacologically active substance. Demonstration of bioequivalence of generic medicine is of great importance. In Europe and the United States generic medicine approval is based in the demonstration of bioequivalence through comparative bioavailability studies in vivo. These arguments are required for marketing approval of generic medicines by the European and North American health authorities. As a measure of the amount of drug absorbed it is used the area under the curve concentration-time (AUC), and as an indicator of the rate of absorption it is measured the peak concentration (Cmax) reached in the concentration-time curve and the time for its occurrence (Tmax). It is known as bioequivalence between two products when they have a comparable bioavailability in the appropriate experimental conditions. The ultimate goal of this process is to make quality drugs available to society and contribute to a more rational use of economic resources in the health system. [ABSTRACT FROM AUTHOR]