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Preparation, Optimization, and Evaluation of Pellets Containing Mesalamine With Natural Gums For Colon Drug Delivery System

Year 2022, Volume: 1 Issue: 47, 35 - 56, 01.03.2022
https://doi.org/10.55262/fabadeczacilik.1078778

Abstract

The purpose of the present work was to formulate colon-targeted mesalamine pellets containing gums of Moringa oleifera Lam. (MOG) and Cyamopsis tetragonolobus Taub. (CTG). Formulation of single stimuli mediated release is also difficult to target colon due to variation in the physiological condition, so in present work, pH dependent and enzyme degradation mechanisms are being used to release of drug at the colonic site. Extrusion and spheronization techniques were used for the preparation of pellets. For formulation optimization, factorial design study 32 was used for the selection of the optimized batch. It was found that high ratio of solvent 80:20 and 10% and 7.5% concentration of MOG and CTG respectively produce optimized pellets showed good physical properties and release for F8M and F8C and after coating it showed in vitro release at the colonic condition and in vivo roentgenographic images for targeting. As to say as advantages, spheronization and extrusion method was proved to have economized, whereas natural gums used to control
release which added advantage as being as inert and biocompatible. This further formulation scope at industrial scales to reduce side effects of synthetic polymer and make it more biocompatible with the body.

References

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Kolona Hedefli Doğal Sakız ve Mesalamin İçeren Pelletlerin Hazırlanması, Optimizasyonu ve Değerlendirilmesi

Year 2022, Volume: 1 Issue: 47, 35 - 56, 01.03.2022
https://doi.org/10.55262/fabadeczacilik.1078778

Abstract

Bu çalışmanın amacı Moringa oleifera Lam. (MOG) ve Cyamopsis tetragonolobus Taub. (CTG)’ den elde edilen sakızları içeren kolona hedefli mesalamin pelletlerinin hazırlanmasıdır. Tekli uyaran aracılı salımın kolona hedefli olarak gerçekleştirilmesinin fizyolojik koşullardan dolayı zor olması nedeniyle salımın kolonda sağlanması için pH ve enzime duyarlı salım mekanizmaları kullanılmıştır. Pelletlerin hazırlanmasında ekstrüzyon ve sferonizasyon teknikleri kullanılmıştır. Formülasyonun optimizasyonunda, optimize serinin seçimi için faktöriyel tasarım çalışması 32 kullanılmıştır. Yüksek çözücü oranı (80:20) ve MOG ve CTG’nin sırasıyla %10 ve %7.5 konsantrasyonlarda kullanımının optimize pelletlerin elde edilmesini
sağladığı saptanmıştır. Elde edilen optimize pelletler hedeflendirme için iyi fiziksel özellik göstermiş ve F8M ve F8C formülasyonları ve bunların kaplanmış formülasyonları kolon ortamında iyi in vitro salım özelliği göstermiş ve in vivo röntgenografik görüntü vermiştir. Avantaj olarak söylemek gerekirse, sferonizasyon ve ekstrüzyon ekonomik açıdan avantaj sağlarken kontrollü salım sağlamak amacıyla kullanılan doğal kaynaklı sakızlar inert ve biyouyumlu yapıları ile avantaj sağlamıştır. Bu formülasyon, endüstriyel ölçeklerde sentetik polimerin yan etkilerini azaltıp vücutla daha biyouyumlu hale getirebilir.

References

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  • Auriemma, G., Mencherini, T., Russo, P., Stigliani, M., Aquino, R. P., & Del Gaudio, P. (2013). Prilling for the development of multi-particulate colon drug delivery systems: Pectin vs. pectin–alginate beads. Carbohydrate Polymers, 92(1), 367–373. Retrieved from https://doi.org/10.1016/j.carbpol.2012.09.056
  • Bendas, E. R., Christensen, J. M., & Ayres, J. W. (2010). Development and in vitro evaluation of mesalamine delayed release pellets and tableted reservoir-type pellets. Drug Development and Industrial Pharmacy, 36(4), 393–404. Retrieved from https://doi.org/10.3109/03639040903213717
  • Bruschi, M. L. (2015). Mathematical models of drug release. In Strategies to Modify the Drug Release from Pharmaceutical Systems (pp. 63–86). Elsevier. Retrieved 22 March 2021 from https://doi.org/10.1016/B978-0-08-100092-2.00005-9
  • Bodea, A., & Leucuta, S. E. (1997). Optimization of propranolol hydrochloride sustained release pellets using a factorial design. International Journal of Pharmaceutics, 154(1), 49–57. Retrieved from https://doi.org/10.1016/S0378-5173(97)00114-2
  • Čalija, B., Cekić, N., Savić, S., Daniels, R., Marković, B., & Milić, J. (2013). pH-sensitive microparticles for oral drug delivery based on alginate/oligochitosan/Eudragit® L100-55 “sandwich” polyelectrolyte complex. Colloids and Surfaces B: Biointerfaces, 110, 395–402. Retrieved from https://doi.org/10.1016/j.colsurfb.2013.05.016
  • Cao, Q., Jin, L., Ding, Y., Zhang, Y., & Xu, X. (2016). A novel pH–enzyme-dependent mesalamine colon-specific delivery system. Drug Design, Development and Therapy, 2021. Retrieved from https://doi.org/10.2147/DDDT.S107283
  • Costa, F. O., Sousa, J. J. S., Pais, A. A. C. C., & Formosinho, S. J. (2003). Comparison of dissolution profiles of Ibuprofen pellets. Journal of Controlled Release, 89(2), 199–212. Retrieved from https://doi.org/10.1016/S0168-3659(03)00033-6
  • Deshpande, R. D., Gowda, D. V., & Mahammed, N. (2013). Design of Pistacia lentiscus (mastic gum) controlled release spheroids and investigating the influence of roll compaction. Industrial Crops and Products, 44, 603–610. Retrieved from https://doi.org/10.1016/j.indcrop.2012.09.014
  • Dubernet, C., Benoit, J. P., Peppas, N. A., & Puisieux, F. (1990). Ibuprofen-loaded ethylcellulose microspheres: Release studies and analysis of the matrix structure through the Higuchi model. Journal of Microencapsulation, 7(4), 555–565. Retrieved from https://doi.org/10.3109/02652049009040479
  • Eriksson, M., Alderborn, G., Nyström, C., Podczeck, F., & Newton, J. M. (1997). Comparison between and evaluation of some methods for the assessment of the sphericity of pellets. International Journal of Pharmaceutics, 148(2), 149–154. Retrieved from https://doi.org/10.1016/S0378-5173(96)04845-4
  • Friciu, M. M., Le, T. C., Ispas-Szabo, P., & Mateescu, M. A.(2013). Carboxymethyl starch and lecithin complex as matrix for targeted drug delivery: I. Monolithic mesalamine forms for colon delivery. European Journal of Pharmaceutics and Biopharmaceutics 85(3), 521–530. Retrieved from https://doi.org/10.1016/j.ejpb.2013.03.007
  • Hamedelniel, E. I., Bajdik, J., & Pintye-Hódi, K. (2010). Optimization of preparation of matrix pellets containing ethylcellulose. Chemical Engineering and Processing: Process Intensification, 49(1), 120–124. Retrieved from https://doi. org/10.1016/j.cep.2009.12.002
  • Hanauer, S. B. (1998). Dose-ranging study of mesalamine (PENTASA) enemas in the treatment of acute ulcerative proctosigmoiditis: Results of a multicentered placebo-controlled trial. Inflammatory Bowel Diseases, 4(2), 79–83.
  • Hanauer, S., Schwartz, J., Robinson, M., Roufail, W., Arora, S., Cello, J., & Safdi, M. (1993). Mesalamine capsules for treatment of active ulcerative colitis: Results of a controlled trial. American Journal of Gastroenterology (Springer Nature), 88(8).
  • Hedin, C., Whelan, K., & Lindsay, J. O. (2007). Evidence for the use of probiotics and prebiotics in inflammatory bowel disease: a review of clinical trials. Proceedings of the Nutrition Society, 66(3), 307–315. Retrieved from https://doi.org/10.1017/S0029665107005563
  • Hileman, G. A., Goskonda, S. R., Spalitto, A. J., & Upadrashta, S. M. (1993). Response surface optimization of high dose pellets by extrusion and spheronization. International Journal of Pharmaceutics, 100(1–3), 71–79. Retrieved from https://doi.org/10.1016/0378-5173(93)90077-S
  • Ige, P. P., & Gattani, S. G. (2012). Design and in vitro and in vivo characterization of mucoadhesive matrix pellets of metformin hydrochloride for oral controlled release: A technical note. Archives of Pharmacal Research, 35(3), 487–498. Retrieved from https://doi.org/10.1007/s12272-012-0312-7
  • Isaac, G. S. (2018). In Pellets: a general overview, Pharmaceutical Pelletization Technology. informa health care, New York, London
  • Joshi, A., Pund, S., Nivsarkar, M., Vasu, K., & Shishoo, C. (2008). Dissolution test for site-specific release isoniazid pellets in USP apparatus 3 (reciprocating cylinder): Optimization using response surface methodology. European Journal of Pharmaceutics and Biopharmaceutics, 69(2), 769–775. Retrieved from https://doi.org/10.1016/j.ejpb.2007.11.020
  • Kaffash, E., Saremnejad, F., Abbaspour, M., Mohajeri, S. A., Garekani, H. A., Jafarian, A. H., … Nokhodchi, A. (2019). Statistical optimization of alginate-based oral dosage form of 5-aminosalicylic acid aimed to colonic delivery: In vitro and in vivo evaluation. Journal of Drug Delivery Science and Technology, 52, 177–188. Retrieved from https://doi.org/10.1016/j.jddst.2019.04.006
  • Kakar, S., Batra, D., & Singh, R. (2013). Preparation and evaluation of magnetic microspheres of mesalamine (5-aminosalicylic acid) for colon drug delivery. Journal of Acute Disease, 2(3), 226–231. Retrieved from https://doi.org/10.1016/S2221-6189(13)60132-8
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There are 55 citations in total.

Details

Primary Language English
Subjects Pharmacology and Pharmaceutical Sciences
Journal Section Research Articles
Authors

Rijawan Rajjak Pathan This is me

Aquil-ur-rahim Sıddıquı This is me

Publication Date March 1, 2022
Submission Date July 9, 2021
Published in Issue Year 2022 Volume: 1 Issue: 47

Cite

APA Pathan, R. R., & Sıddıquı, A.-u.-r. (2022). Preparation, Optimization, and Evaluation of Pellets Containing Mesalamine With Natural Gums For Colon Drug Delivery System. Fabad Journal of Pharmaceutical Sciences, 1(47), 35-56. https://doi.org/10.55262/fabadeczacilik.1078778