PURPOSE The primary aim of the present study was to assess the pharmacokinetic bioequivalence between a generic formulation of meloxicam 15 mg tablets (Meloxicam Hexal) and its respective brand product (Mobic), in order to verify whether the generic product conforms to the regulatory standards of bioequivalence in the postmarketing setting. As a secondary exploratory aim, the pharmacodynamic ef...

Croscarmellose sodium is a very commonly used pharmaceutical additive approved by the US Food and Drug Administration. It is used in injectable preparations as a suspending agent to promote solubilization of compounds with poor water solubility; it is also present in tablets as binder, glidant and antiadherent, in bulk laxatives as active principle and as an additive in food products. Croscarme...

The methodology and criteria for bioequivalence testing have been firmly established by the Food and Drug Administration (FDA). For certain drugs with a narrow therapeutic index (e.g., digoxin, levothyroxine, warfarin), generic substitution may not be advisable or even allowable, depending on the substitution laws of individual states. Digoxin and levothyroxine tablets are examples of drugs for...

A bioequivalence study of two verapamil formulations (generic verapamil tablets and Isoptin® tablets) was performed by comparing pharmacokinetic parameters of the parent drug and its major metabolite, norverapamil following a single dose administration of 80 mg verapamil hydrochloride in 22 healthy volunteers according to a randomized, two-period, crossover-design study. Moreover, the feasibili...

A rapid, sensitive and reproducible HPLC method using amperometric detector was developed and validated for the analysis of clarithromycin in human plasma. The separation was achieved on a monolithic silica column (MZ- C8 125×4.0 mm) using acetonitrile- methanol-potassium dihydrogen phosphate buffer (40:6:54,v/v), with pH of 7.5, as the mobile phase at a flow rate of 1.5 mL/min. The assay enabl...

BACKGROUND In human medicine, adverse outcomes associated with switching between bioequivalent brand name and generic antiepileptic drug products is a subject of concern among clinicians. In veterinary medicine, epilepsy in dogs is usually treated with phenobarbital, either with the standard brand name formulation Luminal(®) or the veterinary products Luminal(®) vet and the generic formulation ...

Aim The angiotensin-converting enzyme inhibitor, enalapril, is considered a first-line treatment for chronic heart failure in children. However, there lack of an age-appropriate formulation and tablet splitting, although not recommended, common, attempt, to provide suitable doses paediatric use. An analysis currently available UK brands explored the accuracy splitting low-dose tablets enalapril...

Hypolipidemic agents have been shown to be helpful in the primary and secondary prevention of cardiovascular disease. Statins are frequently administered treat hyperlipidemia. Although there many statins on market today, atorvastatin is one that most recommended. The medications must meet required physical qualities contain right quantity active medicinal components. goal study was assess value...