SUBSTANTIATION OF SELECTION OF EXCIPIENTS FOR OBTAINING TABLETS BASED ON MALVA SYLVESTRIS L. AND PLANTAGO LANCEOLATA L. DRY EXTRACTS
DOI:
https://doi.org/10.11603/2312-0967.2018.3.9358Keywords:
pharmaceutical factors, excipients, quality indicators, tablets, extracts of Malva sylvestris L. and Plantago lanceolata L.Abstract
The aim of the work. Study of the pharmaceutical factors influence on the some quality indicators of the tablets in order to selection of the best excipients for the development of the composition and technology of new complex tableted medicine preparation based on Malva sylvestris and Plantago lanceolata L. leaves dry extracts obtained by method of wet granulation.
Materials and Methods. The main active substances are dry extracts of Malva sylvestris and Plantago lanceolata leaves, 16 excipients combined into 4 groups of pharmaceutical factors. The tablets were obtained by the method of wet granulation. Investigation of the influence of excipients on the uniformity of tablets weight, friability, tablets resistance for crushing, and disintegration of tablets in accordance with the requirements of the SPF, second editions, were carried out. The stability of tablets on moisture was studied too.
Results and Discussion. The article is devoted to the study of the influence of pharmaceutical factors on some quality indicators of the tablets based on the Malva sylvestris L. and Plantago lanceolata L. dry extracts. The influence of 4 qualitative factors on the main indicators of the quality of tablets based on the Malva sylvestris L. and Plantago lanceolata L. dry extracts have been studied with using the mathematical planning of the experiment (4x4 Greek-Latin square). The ranging rows of the advantages for excipients influence on the 6 indicators of the tablets were constructed. The influence of 16 excipients on the uniformity of the tablets weight, friability, tablets resistance for crushing, and disintegration of the tablets and stability of tablets on moisture have been investigated.
Conclusions. Based on the obtained results, the best excipients have been selected for the development of the composition and technology of a new complex tableted medicine preparation based on Malva sylvestris and Plantago lanceolata L. dry extracts obtained by method of wet granulation, such as: microcrystalline cellulose MCC 101, polyplazm XL-10, sodium carboxymethyl starch, silicon colloidal dioxide, non-silicone US-25, 5 % starch paste.
References
Beley SYa, Hroshovyi TA, Beley NM. [Investigation of the pharmaceutical factors influence on technological properties of the compression mixture аnd some quality indicators of tablets based on Malva Sylvestris L. and Plantago lanceolata L. dry extracts]. Farmats zhurn. 2017;4: 41-9. Ukrainian.
Al-Jumaily EF, Abdul-Ratha HA, Raheema RH. Extraction and purification of Tannins from Plantago lanceolata L. and assessment their antibacterial activity on pathogenesis of enteropathogenic E.Coli in vitro and in vivo. An International Peer-Reviewed Journal. 2012;1: 17-21.
Assessment report on Plantago lanceolata L., folium based on Article 16d (1), Article 16f and Article 16h of Directive 2001/83/EC as amended (traditional use). European Medicines Agency, EMA/HMPC/437859/2010 Committee on Herbal Medicinal Products (HMPC) 2012; 24.
Seyed Mehdi Razavi, Gholamreza Zarrini, Ghader Molavi. Bioactivity of Malva Sylvestris L., medicinal plant from Iran. Iranian Journal of Basic Medical Sciences. 2011;6: 574-9.
Chiclana CF, Enrique A, Consolini AE. Actividad Antiinflamatoria Local de Malva sylvestris L. (Malvaceae) en el Edema Inducido por Carragenina en Ratas. Latin American Journal of Pharmacy. 2009;28(2): 275-8.
State Pharmacopoeia of Ukraine: in 3 vol. State Enterprise “Ukrainian Research Center expert pharmacopoeia quality medicines.” – 2nd ed. [Держ. п-во «Український науковий фармакопейний центр якості лікарських засобів». Державна Фармакопея України: 2-е вид. Допов.] Kharkiv: State Enterprise “Ukrainian Research Center expert pharmacopoeia drug quality”; 2015. Ukrainian.
Hroshovyi TA, Martseniuk VP, Kucherenko LI, Vronska LV, Hurieieva CM. Mathematical planning of experiment in pharmacy. [Математичне планування експерименту в фармації] Ternopil: Ternopil State Medical University; 2008. Ukrainian.
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