Acta Pharmaceutica Hungarica

HPLC Assay And Stability Testing of Adrenaline from Compounded Rectal Suppositories

Bálint Berente — 2025-06-15

The adrenaline content of Tonogen (adrenaline)+benzocaine HCl+Peru balsam+oleum ricini+adeps solidus rectal suppository, a commonly prescribed non-official topical compounded preparation for piles (hemorrhoids) in Hungary, manufactured in a community pharmacy by fusion molding, was assayed and its stability during storage at 5-6 °C for 28 days in primary and secondary packaging was determined by a validated HPLC method. The 68 rectal suppositories manufactured showed a variance of 114% to 58% in their actual adrenaline contents compared to the nominal average adrenaline concentration in the bulk mass at time t0 (the latter value was measured in the last suppository). Within the group of suppositories included in the stability study, the lowest measured concentration (suppository Nr. 41; 7.64 μg/g) was 77% of the nominal average bulk concentration at time t1, while the highest measured concentration (suppository Nr. 46; 11.35 μg/g) was 114% of the nominal average bulk concentration at time t0. During the storage period, the adrenaline content of the suppositories did not show any significant decrease. The inhomogeneity of adrenaline contents found among suppositories did not show any significant trend in the function of manufacturing order (if the last suppositories manufactured were excluded).

Intravenous multivitamin shortage management for parenteral nutrition

Stefan Mühlebach — 2025-06-15

Objectives The objective was to elucidate the current practice of managing parenteral nutrition duringintravenous multivitamin shortages in Switzerland and the impact on patients.

Methods We conducted 17 structured interviews with experts involved in parenteral nutrition supply(healthcare professionals, a public servant, and industry representatives) and patients on home parenteral nutrition.

Results Awareness and experience with intravenous multivitamin shortages was high among professionals but not in patients. Overall, eight (47%) of the professionals experienced long-lasting shortages (>90 days). Mentioned reasons for shortages were packaging and transport issues, problems in the procurement of raw materials, lack of personnel due to the COVID-19 pandemic, changed industrial manufacturing prioritizing, e.g., for mRNA vaccines, the 2021 Suez Canal obstruction, low market price, and national authorization withdrawal.

Conclusions Managing intravenous multivitamin shortages has become a common task. European guidelinesincluding prioritization of patients relying on intravenous multivitamins and trace elements are warranted.

The emergence of the dominance of synthetic medicines before the era of modern clinical trials – a Hungarian perspective; Part I

Dobson Szabolcs — 2025-12-17

The emergence of the dominance of synthetic medicines is not only due to their purely scientific value, as is generally believed, but has been fundamentally facilitated by a number of societal factors that are usually overlooked: the patent system, demography, modern wars, the emergence of social insurance and mass health care, with the widespread operation of medical practices and pharmacies, the spread of industry-made finished medicinal products, the emergence of marketing by the pharmaceutical industry and the drug authorization system. This article analyses their role in the emerging dominance of synthetic medicines. Part I. of this publication discusses the significance of science, patent legislation and the legal system, demography, wars, and social insurance and public health (the medicalization of society).

Bioequivalence of two different formulations of rivaroxaban film-coated tablet

Anita Orosz — 2025-12-17

Aims: Studies aimed to evaluate the bioequivalence of 10 mg and 20 mg of Rivaroxaban film-coated tablets developed by Gedeon Richter Plc. (Hungary) compared to the reference product Xarelto^®(Bayer AG, Germany).

Methods: Two randomized, open-label, two-period, two-sequence crossover studies were conducted in healthy male subjects. Study A assessed the 10 mg dose under fasting conditions (n=42), while Study B evaluated the 20 mg dose under fed conditions (n=30). Pharmacokinetic parameters including AUCₜ, AUC_inf, and Cₘₐₓ were determined using validated LC-MS/MS methods. Bioequivalence was concluded if the 90% confidence intervals (CIs) for the test/reference ratios of these parameters fell within the 80.00–125.00% range.

Results: In Study A, the geometric mean ratios (GMRs) for AUCₜ and Cₘₐₓ were 97.32% and 90.39%. In Study B, the GMRs for AUCₜ and Cₘₐₓ were 98.35% and 95.98%. All 90% CIs were within the predefined bioequivalence limits. Both formulations were well tolerated. Only mild and well-known treatment-emergent adverse events (TEAEs) were reported, without any treatment discontinuation.

Conclusions: The 10 mg and 20 mg Rivaroxaban formulations developed by Gedeon Richter Plc. are bioequivalent to Xarelto^® and are safe and well tolerated. These results support their use as clinically interchangeable alternatives to the reference product.