PREPARATION AND IN VIVO EVALUATION OF PIROXICAM SUBGLINGUAL POLYMERIC FILMS

Yıl 2024, Cilt: 48 Sayı: 3, 1128 - 1134, 10.09.2024

Okan Ali Aksoy , Esra Merve Zanbak Çotaoğlu , Gizem Rüya Topal , Berk Alp Göksel , Özgür Eşim , Cansel Köse Özkan , Ayhan Savaşer , Yalçın Özkan

https://doi.org/10.33483/jfpau.1514714

Öz

Objective: Although it is known that different drug applications can increase the effect of drugs, there are many studies that shows the superiority of different dosage forms. The reason of these different results is due to the different properties of used active ingredients. In this study, the potential use of piroxicam sublingual polymeric film application was investigated.
Material and Method: In the study, maltodextrin and pullulan sublingual films containing piroxicam were prepared, and plasma levels of the drug were investigated in a healthy rabbit in vivo model.
Result and Discussion: In vivo results showed that piroxicam reached its highest plasma concentrations within 10 hours after a single dose administration. Additionally, a second peak corresponding to possible gastrointestinal absorption did not occur in the plasma drug profile. In summary, it has been determined that piroxicam-loaded sublingual polymeric film application can be used to provide an analgesic effect.

Anahtar Kelimeler

Film, maltodextrin, pharmacokinetic, piroxicam, pullulan

PİROKSİKAM DİLALTI POLİMERİK FİLMLERİNİN HAZIRLANMASI VE İN VİVO DEĞERLENDİRİLMESİ

Öz

Amaç: Farklı ilaç uygulamalarının etken maddelerin etkinliğini arttırabildiği bilinmesine rağmen hangi ilaç salım sisteminin daha iyi olduğu konusunda birçok çalışma bulunmaktadır. Bunun nedeninin etken maddenin özelliklerine göre bu uygulamaların daha büyük avantaj sağlamasıdır. Bu çalışmada piroksikam dilaltı polimerik film uygulamasının potansiyel kullanımı araştırılmıştır.
Gereç ve Yöntem: Çalışmada piroksikam dilaltı maltodekstrin ve pullulan içeren filmler hazırlanmış ve sağlıklı tavşan in vivo modelinde ilacın plazma düzeyleri araştırılmıştır.
Sonuç ve Tartışma: İn vivo sonuçlar, tek doz uygulamadan sonra 10 saat içinde piroksikamın en yüksek plazma konsantrasyonlarına ulaştığını göstermiştir. Ayrıca plazma ilaç profilinde olası gastrointestinal emilime karşılık gelen ikinci bir tepe noktası oluşmamıştır. Özetle, piroksikam yüklü dilaltı polimerik film uygulamasının analjezik etkinin sağlanması amacıyla kullanılabilir özellikte olduğu tespit edilmiştir.

Anahtar Kelimeler

Farmakokinetik, film, maltodekstrin, piroksikam, pullulan

Kaynakça

• 1. Baumgartner, R., Teubl, B.J., Tetyczka, C., Roblegg, E. (2016). Rational design and characterization of a nanosuspension for intraoral administration considering physiological conditions. Journal of Pharmaceutical Sciences, 105(1), 257-267. [CrossRef]
• 2. Dubashynskaya, N.V., Petrova, V.A., Skorik, Y.A. (2024). Biopolymer drug delivery systems for oromucosal application: Recent trends in pharmaceutical R&D. International Journal of Molecular Sciences, 25(10), 5359. [CrossRef]
• 3. Chatap, V.K., Maurya, A.K., Deshmukh, P.K., Zawar, R.L. (2013). Formulation and evaluation of nisoldipne sublingual tablets using pullulan & chitosan for rapid oromucosal absorption. Advances in Pharmacology and Pharmacy, 1(1), 18-25. [CrossRef]
• 4. Aksoy, O.A., Zanbak Çotaoğlu, M., Fatsa, T., Topal, G.R., Eşim, Ö., Göksel, B.A., Hoşbul, T., Özkan, C. K., Savaşer, A., Özkan, Y. (2023). Preparation of Piroxicam nanosuspensions by high pressure homogenization and evaluation of improved bioavailability. Drug Development and Industrial Pharmacy, 49(12), 715-722.[CrossRef]
• 5. Lai, F., Pini, E., Angioni, G., Manca, M.L., Perricci, J., Sinico, C., Fadda, A.M. (2011). Nanocrystals as tool to improve piroxicam dissolution rate in novel orally disintegrating tablets. European Journal of Pharmaceutics and Biopharmaceutics, 79(3), 552-558. [CrossRef]
• 6. Hirpara, F., Debnath, S.K., Saisivam, S.J.B. (2014). Optimization & screening of different film forming polymers and plasticizers in fast dissolving sublingual film. International Journal of Pharmacy and Pharmaceutical Sciences, 6(6), 41-42.
• 7. Siemann, U. (2005). Progress in Colloid and Polymer Science. In: N.Stribeck and B.Smarsly (eds.), Solvent cast technology-a versatile tool for thin film production, in Scattering methods and the properties of polymer materials, (pp.1-14). 2005, Berlin, Springer. [CrossRef]
• 8. Childs, S.L., Hardcastle, K.I. (2007). Cocrystals of piroxicam with carboxylic acids. Crystal Growth & Design, 7(7), 1291-1304. [CrossRef]
• 9. Sheth, A.R., Lubach, J.W., Munson, E.J., Muller, F.X., Grant, D.J.W. (2005). Mechanochromism of piroxicam accompanied by intermolecular proton transfer probed by spectroscopic methods and solid-phase changes. Journal of the American Chemical Society, 127(18), 6641-6651. [CrossRef]
• 10. Esim, Ö. (2019). Preparation and in vitro evaluation of methylene blue films for treatment of oral mucosal diseases. Gülhane Medical Journal, 61(3), 109. [CrossRef]
• 11. Ramesh, V., Meenakshi, S., Jyothirmayee, N., Bullebbai, M., Noorjahan, S., Rajeswari, G., Babu, G.N., Madhavi, D.L. (2016). Enhancement of solubility, dissolution rate and bioavailability of BCS Class II Drugs. International Journal of Pharma And Chemical Research, 2(2), 2395-3411.
• 12. US Pharmacopeia (USP) Web site. (2016). Retrieved May 1, 2016 from https://www.usp.org/sites/default/files/usp/document/our-work/biologics/USPNF810G-GC-1132-2017-01.pdf/. Erişim tarihi: 10.06.2024.
• 13. Esim, O., Ozkan, C.K., Kurbanoglu, S., Arslan, A., Tas, C., Savaser, A., Ozkan, S.A., Ozkan, Y. (2019). Development and in vitro/in vivo evaluation of dihydroergotamine mesylate loaded maltodextrin-pullulan sublingual films. Drug Development and Industrial Pharmacy, 45(6), 914-921. [CrossRef]
• 14. Bredenberg, S., Duberg, M., Lennernäs, B., Lennernäs, H., Pettersson, A., Westerberg, M., Nyström, C. (2003). In vitro and in vivo evaluation of a new sublingual tablet system for rapid oromucosal absorption using fentanyl citrate as the active substance. European Journal of Pharmaceutical Sciences, 20(3), 327-334. [CrossRef]
• 15. Kate, V.K., Payghan, S.A., Shinde, A.J. (2013). Single dose pharmacokinetics of mucoadehsive fast disintegrating sublingual tablet of piroxicam in rabbits. Inventi Impact: Pharmacokinetics & Pharmacodynamics, 2013(3), 137-141.