<abstract xmlns="http://www.w3.org/1999/xhtml">

<sec><h3>Aim</h3>
Vildagliptin/metformin 50 mg/1000 mg film coated tablets (Sensityn®) is being developed for the treatment of type 2 diabetes mellitus. An open label, crossover, bioequivalence study (phase I) was conducted to assess the bioequivalence between Sensityn® Film Coated Tablets (Test Product/Alpha Pharma Industries, a subsidiary of Cigalah Healthcare LLC, KAEC, Saudi Arabia) and Galvusmet® Film Coated Tablets (Reference product/Novartis Pharma, Switzerland), in healthy adults under fed conditions. Safety and tolerance were evaluated as secondary endpoints.
</sec>
<sec><h3>Materials and methods</h3>
A randomized study with two treatments, two periods, crossover, open-label, laboratory-blind, single dose, with a washout period of seven days under fed conditions in 36 healthy male subjects. These were administered medicinal drug product (Sensityn®) or the reference medicinal product (Galvusmet®); both as a single 50 mg/1000 mg oral dose, under fed conditions. Blood samples were collected for pharmacokinetic analysis before treatment and until 24.00h post-dosing in each study period. ANOVA analysis (test sequence, subjects’ nested within sequence, product and period effect) was performed using a 5% significance level for logarithmic and untransformed data for Cmax AUC0-t and AUC0-∞ and for untransformed data for Tmax, Kelimination (λz) and half-life.
</sec>
<sec><h3>Results</h3>
The results showed that Cmax, AUC0-t, and AUC0-∞ have passed the 90% CI acceptance limits of 80.00%–125.00% for vildagliptin and metformin. Consequently, the bioequivalence of Sensityn® and Galvusmet® film coated tablets was demonstrated under fed conditions. Treatment emergent adverse events were reported by 3 subjects and 1 subject following the administration of Sensityn® and the Galvusmet®, respectively.
</sec>
<sec><h3>Conclusion</h3>
The present findings confirmed that Sensityn®, the test medicinal product is bioequivalent to Galvusmet®, the reference medicinal product, in the rate and extent of absorption. Also, it has comparable safety profile. These findings support the continued development of vildagliptin/metformin 50 mg/1000 mg film coated tablets (Sensityn®) for use in patients with type 2 diabetes mellitus.
</sec>
</abstract>

Alpha Pharma, Research & Development Dept.

A Randomized, Two-Treatments, Two-Periods, Crossover, Open label, Laboratory-Blind, Single Dose Bioequivalence Study between Vildagliptin/Metformin 50 mg/1000 mg Film Coated Tablets (Sensityn®) and Galvusmet® 50 mg/1000 mg Film Coated Tablets in healthy adults under fed conditions

<abstract xmlns="http://www.w3.org/1999/xhtml">

A revolutionary concept for achieving long-term medication release is the gastroretentive <italic>in situ</italic> gelling system. The goal of this research was to formulate and test a gastroretentive <italic>in situ</italic> gel for ketoprofen delivery to targeted site to increase the residence and delivery time. Ketoprofen gastroretentive <italic>in situ</italic> gels were synthesized using a cation-driven gelation approach using various combinations and concentrations of polymers such as gellan gum, sodium alginate, and hydroxypropyl methylcellulose (HPMC) K100M. Visual appearance, pH, viscosity, <italic>in vitro</italic> gelation, <italic>in vitro</italic> buoyancy, drug content, density measurement, gel strength measurement, water uptake, and <italic>in vitro</italic> drug release were all evaluated. The total floating time was more than 12 h, with a floating lag time of less than 2 min. The formulations showed pH ranging from 6.89 to 7.61 and drug content ranging from 82.01% to 95.53%. For 11 h, the percent cumulative drug release of formulations F5 and F14, which contained a greater concentration of polymer sodium alginate (1.5%) and a combination of gellan gum and HPMC K100M (0.175% and 0.2%), was 84.10% and 85.49%, respectively. <italic>In vitro</italic> dissolution experiments and stability investigations both revealed no significant changes in drug content. The findings revealed that the formulated <italic>in situ</italic> gels aided in extending gastric residence duration, allowing the drug to be released in the stomach.
</abstract>

Formulation and Evaluation of Gastroretentive <italic>In Situ</italic> Gelling System of Ketoprofen

<abstract xmlns="http://www.w3.org/1999/xhtml">

The present work describes the synthesis, physico-chemical characteristics, antioxidative properties, and high-performance liquid chromatography (HPLC) enantioseparation of novel, potentially bioactive aryloxyaminopropanols – derivatives of naphthalen-2-ol modified in the basic part of their molecules. Reaction of naphthalene-2-ol with chloromethyloxirane leads to 2-[(naphthalen-2-yloxy)methyl]oxirane, which reacts in the next step with branched aliphatic amines (isopropylamine, <italic>tert</italic>-butylamine, and dimethylamine), aromatic amines (aniline, 3,4-dimethoxyphenylethylamine), and heterocyclic amines (pyrrolidine, imidazole, 2-methylimidazole, piperidine, morpholine, 4-methylpiperidine, or 2-methoxyphenylpiperidine). The target compounds were isolated in the form of free bases, as well as their salts with fumaric or hydrochloric acid. Their purity was established by thin-layer chromatography and their IR, UV, 1H-NMR, and 13C-NMR spectra were recorded. The antioxidant activities of prepared compounds were measured by the 2,2′-azino-bis(3-ethylbenzothiazoline-6-sulfonic acid (ABTS) method and they were compared with the values for the corresponding salts. Enantioseparation was accomplished by means of enantioselective HPLC using amylose tris(3,5-dimethylphenyl)carbamate (Chiralpak AD), as well as Chirobiotic T (native teicoplanin) in some cases.
</abstract>

Department of Chemical Theory of Drugs, Faculty of Pharmacy

Institute of Analytical Chemistry, Faculty of Chemical and Food Technology

Slovak University of Technology in Bratislava

Synthesis, antioxidant activity, and HPLC enantioseparation of aryloxyaminopropanols derived from naphthalen-2-ol

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European Pharmaceutical Journal

  Formerly Acta Facultatis Pharmaceuticae Universitatis Comenianae.  All areas of pharmaceutical and related sciences.  Original research articles.    Why subscribe and read   To get informed on the research in pharmaceutical and related sciences mainly in the central Europe,  Articles written by young talented enthusiastic researchers,  To find new co operations.   Why submit   Official journal of Pharmaceutical Faculty, the oldest faculty of Pharmacy in former Czechoslovakia, keeping the tradition in pharmaceutical education in central Europe,  Fair and constructive review by the experts in the field,  Articles abstracted by online indexing services and databases.   Rejection Rate   50%   Archiving  Sciendo archives the contents of this journal in Portico - digital long-term preservation service of scholarly books, journals and collections.  Plagiarism Policy  The editorial board is participating in a growing community of Similarity Check System's users in order to ensure that the content published is original and trustworthy. Similarity Check is a medium that allows for comprehensive manuscripts screening, aimed to eliminate plagiarism and provide a high standard and quality peer-review process. 

European Pharmaceutical Journal

Volume 70 (2023): Issue 2 (December 2023)

Original Paper

A Randomized, Two-Treatments, Two-Periods, Crossover, Open label, Laboratory-Blind, Single Dose Bioequivalence Study between Vildagliptin/Metformin 50 mg/1000 mg Film Coated Tablets (Sensityn^®) and Galvusmet^® 50 mg/1000 mg Film Coated Tablets in healthy adults under fed conditions

Formulation and Evaluation of Gastroretentive In Situ Gelling System of Ketoprofen

Synthesis, antioxidant activity, and HPLC enantioseparation of aryloxyaminopropanols derived from naphthalen-2-ol

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