Monocomponent folic acid dietary supplements marketed in Serbia: Pharmaceutical technical investigation and characteristics
Monokomponentni dijetetski suplementi folne kiseline na tržištu Republike Srbije - farmaceutsko-tehnološka ispitivanja i karakteristike
Abstract
Introduction. Disintegration of the solid dosage form of dietary supplements and folic acid dissolution rate are of particular importance for its bioavailability. However, current legislation in the Republic of Serbia does not set criteria for the pharmaceutical technical quality of dietary supplements. The United States Pharmacopoeia, on the other hand, gives testing standards for disintegration, dissolution and weight variation of dietary supplements. Aim. The objective of this study was to investigate and compare pharmaceutical technical quality of solid dosage forms of dietary supplements marketed in Serbia, with regard to the United States Pharmacopoeia standards for dietary supplements and European Pharmacopoeia standards for solid dosage forms of pharmaceutical preparations. Methods. Seven monocomponent folic acid dietary supplements commercially available in Serbia, from which three uncoated tablets, three coated tablets and one hard capsules, were subjected, depending on the d...osage form, to the weight variation, friability, hardness, disintegration and dissolution testing. Conclusion. The obtained results have shown that six out of seven investigated products complies with United States Pharmacopoeia standards for pharmaceutical technical quality of dietary supplements, while only one (hard capsules) failed to meet the requirements for disintegration.
Uvod. Za biološku raspoloživost folne kiseline iz čvrstih doziranih oblika dijetetskih suplemenata, od posebnog značaja su raspadljivost i brzina rastvaranja folne kiseline. Međutim, trenutni zakonski propisi u Republici Srbiji, kao i u drugim evropskim zemljama, ne postavljaju zahteve za farmaceutsko-tehnološki kvalitet dijetetskih suplemenata, za razliku od Američke farmakopeje koja navodi zahteve za farmaceutsko-tehnološki kvalitet dijetetskih suplemenata u pogledu raspadljivosti, brzine rastvaranja i variranja mase. Cilj. Cilj rada je bio da se ispitaju i uporede parametri od značaja za farmaceutsko-tehnološki kvalitet čvrstih doziranih oblika monokomponentnih dijetetskih suplemenata folne kiseline, na tržištu Republike Srbije, u odnosu na propise Američke farmakopeje za dijetetske suplemente i Evropske farmakopeje za čvrste dozirane oblike farmaceutskih proizvoda. Metod rada. Sedam monokomponentnih dijetetskih suplemenata folne kiseline dostupnih na tržištu Republike Srbije, od če...ga jedan u obliku tvrdih kapsula, tri u obliku neobloženih i tri u formi obloženih tableta, podvrgnuto je, zavisno od vrste doziranog oblika aktivnog sastojka odgovarajućeg suplementa, ispitivanju variranja mase, frijabilnosti, čvrstoće, raspadljivosti i brzine rastvaranja folne kiseline. Zaključak. Dobijeni rezultati su pokazali da od ukupno sedam ispitivanih monokomponentnih dijetetskih suplemenata folne kiseline, šest u potpunosti ispunjava zahteve Američke farmakopeje za farmaceutsko-tehnološki kvalitet dijetetskih suplemenata, a samo jedan ispitivani preparat (tvrde kapsule) nije odgovarao zahtevima i to samo u pogledu raspadljivosti.
Keywords:
folic acid / dietary supplements / pharmaceutical technical quality / disintegration / folic acid dissolution / folna kiselina / dijetetski suplementi / farmaceutsko-tehnološki kvalitet / raspadljivost / brzina rastvaranja folne kiselineSource:
Hrana i ishrana, 2015, 56, 2, 31-36Publisher:
- Društvo za ishranu Srbije, Beograd
Collections
Institution/Community
PharmacyTY - JOUR AU - Čalija, Bojan AU - Đuriš, Jelena AU - Dobričić, Vladimir AU - Vidović, Bojana AU - Milić, Jela AU - Šobajić, Slađana PY - 2015 UR - https://farfar.pharmacy.bg.ac.rs/handle/123456789/2478 AB - Introduction. Disintegration of the solid dosage form of dietary supplements and folic acid dissolution rate are of particular importance for its bioavailability. However, current legislation in the Republic of Serbia does not set criteria for the pharmaceutical technical quality of dietary supplements. The United States Pharmacopoeia, on the other hand, gives testing standards for disintegration, dissolution and weight variation of dietary supplements. Aim. The objective of this study was to investigate and compare pharmaceutical technical quality of solid dosage forms of dietary supplements marketed in Serbia, with regard to the United States Pharmacopoeia standards for dietary supplements and European Pharmacopoeia standards for solid dosage forms of pharmaceutical preparations. Methods. Seven monocomponent folic acid dietary supplements commercially available in Serbia, from which three uncoated tablets, three coated tablets and one hard capsules, were subjected, depending on the dosage form, to the weight variation, friability, hardness, disintegration and dissolution testing. Conclusion. The obtained results have shown that six out of seven investigated products complies with United States Pharmacopoeia standards for pharmaceutical technical quality of dietary supplements, while only one (hard capsules) failed to meet the requirements for disintegration. AB - Uvod. Za biološku raspoloživost folne kiseline iz čvrstih doziranih oblika dijetetskih suplemenata, od posebnog značaja su raspadljivost i brzina rastvaranja folne kiseline. Međutim, trenutni zakonski propisi u Republici Srbiji, kao i u drugim evropskim zemljama, ne postavljaju zahteve za farmaceutsko-tehnološki kvalitet dijetetskih suplemenata, za razliku od Američke farmakopeje koja navodi zahteve za farmaceutsko-tehnološki kvalitet dijetetskih suplemenata u pogledu raspadljivosti, brzine rastvaranja i variranja mase. Cilj. Cilj rada je bio da se ispitaju i uporede parametri od značaja za farmaceutsko-tehnološki kvalitet čvrstih doziranih oblika monokomponentnih dijetetskih suplemenata folne kiseline, na tržištu Republike Srbije, u odnosu na propise Američke farmakopeje za dijetetske suplemente i Evropske farmakopeje za čvrste dozirane oblike farmaceutskih proizvoda. Metod rada. Sedam monokomponentnih dijetetskih suplemenata folne kiseline dostupnih na tržištu Republike Srbije, od čega jedan u obliku tvrdih kapsula, tri u obliku neobloženih i tri u formi obloženih tableta, podvrgnuto je, zavisno od vrste doziranog oblika aktivnog sastojka odgovarajućeg suplementa, ispitivanju variranja mase, frijabilnosti, čvrstoće, raspadljivosti i brzine rastvaranja folne kiseline. Zaključak. Dobijeni rezultati su pokazali da od ukupno sedam ispitivanih monokomponentnih dijetetskih suplemenata folne kiseline, šest u potpunosti ispunjava zahteve Američke farmakopeje za farmaceutsko-tehnološki kvalitet dijetetskih suplemenata, a samo jedan ispitivani preparat (tvrde kapsule) nije odgovarao zahtevima i to samo u pogledu raspadljivosti. PB - Društvo za ishranu Srbije, Beograd T2 - Hrana i ishrana T1 - Monocomponent folic acid dietary supplements marketed in Serbia: Pharmaceutical technical investigation and characteristics T1 - Monokomponentni dijetetski suplementi folne kiseline na tržištu Republike Srbije - farmaceutsko-tehnološka ispitivanja i karakteristike VL - 56 IS - 2 SP - 31 EP - 36 UR - https://hdl.handle.net/21.15107/rcub_farfar_2478 ER -
@article{ author = "Čalija, Bojan and Đuriš, Jelena and Dobričić, Vladimir and Vidović, Bojana and Milić, Jela and Šobajić, Slađana", year = "2015", abstract = "Introduction. Disintegration of the solid dosage form of dietary supplements and folic acid dissolution rate are of particular importance for its bioavailability. However, current legislation in the Republic of Serbia does not set criteria for the pharmaceutical technical quality of dietary supplements. The United States Pharmacopoeia, on the other hand, gives testing standards for disintegration, dissolution and weight variation of dietary supplements. Aim. The objective of this study was to investigate and compare pharmaceutical technical quality of solid dosage forms of dietary supplements marketed in Serbia, with regard to the United States Pharmacopoeia standards for dietary supplements and European Pharmacopoeia standards for solid dosage forms of pharmaceutical preparations. Methods. Seven monocomponent folic acid dietary supplements commercially available in Serbia, from which three uncoated tablets, three coated tablets and one hard capsules, were subjected, depending on the dosage form, to the weight variation, friability, hardness, disintegration and dissolution testing. Conclusion. The obtained results have shown that six out of seven investigated products complies with United States Pharmacopoeia standards for pharmaceutical technical quality of dietary supplements, while only one (hard capsules) failed to meet the requirements for disintegration., Uvod. Za biološku raspoloživost folne kiseline iz čvrstih doziranih oblika dijetetskih suplemenata, od posebnog značaja su raspadljivost i brzina rastvaranja folne kiseline. Međutim, trenutni zakonski propisi u Republici Srbiji, kao i u drugim evropskim zemljama, ne postavljaju zahteve za farmaceutsko-tehnološki kvalitet dijetetskih suplemenata, za razliku od Američke farmakopeje koja navodi zahteve za farmaceutsko-tehnološki kvalitet dijetetskih suplemenata u pogledu raspadljivosti, brzine rastvaranja i variranja mase. Cilj. Cilj rada je bio da se ispitaju i uporede parametri od značaja za farmaceutsko-tehnološki kvalitet čvrstih doziranih oblika monokomponentnih dijetetskih suplemenata folne kiseline, na tržištu Republike Srbije, u odnosu na propise Američke farmakopeje za dijetetske suplemente i Evropske farmakopeje za čvrste dozirane oblike farmaceutskih proizvoda. Metod rada. Sedam monokomponentnih dijetetskih suplemenata folne kiseline dostupnih na tržištu Republike Srbije, od čega jedan u obliku tvrdih kapsula, tri u obliku neobloženih i tri u formi obloženih tableta, podvrgnuto je, zavisno od vrste doziranog oblika aktivnog sastojka odgovarajućeg suplementa, ispitivanju variranja mase, frijabilnosti, čvrstoće, raspadljivosti i brzine rastvaranja folne kiseline. Zaključak. Dobijeni rezultati su pokazali da od ukupno sedam ispitivanih monokomponentnih dijetetskih suplemenata folne kiseline, šest u potpunosti ispunjava zahteve Američke farmakopeje za farmaceutsko-tehnološki kvalitet dijetetskih suplemenata, a samo jedan ispitivani preparat (tvrde kapsule) nije odgovarao zahtevima i to samo u pogledu raspadljivosti.", publisher = "Društvo za ishranu Srbije, Beograd", journal = "Hrana i ishrana", title = "Monocomponent folic acid dietary supplements marketed in Serbia: Pharmaceutical technical investigation and characteristics, Monokomponentni dijetetski suplementi folne kiseline na tržištu Republike Srbije - farmaceutsko-tehnološka ispitivanja i karakteristike", volume = "56", number = "2", pages = "31-36", url = "https://hdl.handle.net/21.15107/rcub_farfar_2478" }
Čalija, B., Đuriš, J., Dobričić, V., Vidović, B., Milić, J.,& Šobajić, S.. (2015). Monocomponent folic acid dietary supplements marketed in Serbia: Pharmaceutical technical investigation and characteristics. in Hrana i ishrana Društvo za ishranu Srbije, Beograd., 56(2), 31-36. https://hdl.handle.net/21.15107/rcub_farfar_2478
Čalija B, Đuriš J, Dobričić V, Vidović B, Milić J, Šobajić S. Monocomponent folic acid dietary supplements marketed in Serbia: Pharmaceutical technical investigation and characteristics. in Hrana i ishrana. 2015;56(2):31-36. https://hdl.handle.net/21.15107/rcub_farfar_2478 .
Čalija, Bojan, Đuriš, Jelena, Dobričić, Vladimir, Vidović, Bojana, Milić, Jela, Šobajić, Slađana, "Monocomponent folic acid dietary supplements marketed in Serbia: Pharmaceutical technical investigation and characteristics" in Hrana i ishrana, 56, no. 2 (2015):31-36, https://hdl.handle.net/21.15107/rcub_farfar_2478 .