Naslov
Oral dosage testing of dietary supplements used in the treatment of IBD according to the United States Pharmacopeia

Autori
Kovačić, Jelena ; Amidžić Klarić, Daniela ; Jeličić, Mario-Livio ; Perko, Matea ; Klarić, Ilija ; Zubčić, Snježana ; Mornar, Ana

Vrsta, podvrsta i kategorija rada
Sažeci sa skupova, sažetak, znanstveni

Izvornik
28HSKIKi Book of Abstracts / Rogošić, Marko - Zagreb : Hrvatsko društvo kemijskih inženjera i tehnologa (HDKI), 2023, 92-92

Skup
28th Croatian Meeting of Chemists and Chemical Engineers

Mjesto i datum
Rovinj, Hrvatska, 28.03.2023. - 31.03.2023

Vrsta sudjelovanja
Poster

Vrsta recenzije
Međunarodna recenzija

Ključne riječi
IBD ; dietary supplements ; USP

Sažetak
As the number of patients with inflammatory bowel disease (IBD) that use dietary supplements (DS) continues to increase in many countries, the importance of ensuring product quality is of scientific matter. Regulators, health professionals, and manufacturers often disagree on how much quality testing is necessary for DS. This is highlighted by the World Health Organization’s Strategy on Traditional Medicines 2014–2023 [1] where quality is seen as a basis of the DS sector. The United States Pharmacopeia (USP) is an independent, nonprofit, science-based organization whose mission is to improve human health through quality standards and tests for DS. [2] The aim of this research was to perform oral dosage testing based on USP protocols of botanical DS used in the treatment of IBD. 53 samples tested were in multiple oral dosage forms: tablets, hard capsules, soft capsules, powders, and liquid extracts. The following test were performed: Tapped Density <616>, Loss on Drying <731>, Tablet Friability <1216>, Tablet Breaking Force <1217>, Weight Variation <2091>, and Disintegration <2040>. The tests were performed using tapped density testing instrument (PT-DT300), tablet friability test instrument (PTF 100), and tablet disintegration tester (PTZ-S) by Pharma Test (Germany), tablet hardness tester (TBH 125) by Erweka (Germany) and moisture analyzer (DBS 60-3) obtained by Kern & Sohn GmbH (Germany). The lowest tapped density was found for turmeric (CI 25%) and the highest for green chiretta (CI 45%). The tablet breaking force was in the range of 27.7 to 248.5 N. One sample containing black pepper as a botanical ingredient did not meet the requirements of loss on the drying test (5.2%). All investigated tablets met the requirements of the friability test expressed in terms of allowable weight loss (≤0.61%). Investigated tablets and capsules met the requirements of the weight variation test expressed in terms of the allowable deviation from the average weight of the sample (≤7.7% tablets, ≤9.0% capsule). Only one sample did not meet the requirements of the disintegration test as none of investigated 6 tablets had not disintegrated under specified conditions. The challenges in DS science and its regulation provide new opportunities for scientists and regulators to work together both nationally and internationally, and to cooperate to improve public health. Assessments of the quality of DS are needed to provide the scientific information that regulators need.

Izvorni jezik
Engleski

Znanstvena područja
Farmacija

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