Formulation and evaluation of almotriptan controlled release pellets
Abstract: The aim of the present study was to formulate and evaluate Almotriptan pellets. Almotriptan controlled release pellets were prepared by Solution layering technique by using croscarmellose and povidone in former case and three different polymers HPMC K 100, Ethyl cellulose and Eudragit RS 100 as rate controlling polymer in three different ratios like 1:1, 1:1.5 and 1:2 to achieve desired release in later case. Evaluation was performed according to the Pharmacopoeia standards including Drug excipients compatibility, Percentage yield, Particle size distribution, Drug content analysis and in-vitro release study. The best results were found to be using Almotriptan and Eudragit RS 100 in 1:2 ratios. A broad variety of drug release pattern could be achieved by variation of polymers ratios which was optimized to match the target release profile. In comparison of in-vitro release studies for different controlled release formulations, F9 releases 98.54% of drug at the end of 12th hour and was considered as best formulation. Stability study has shown no significant change in the drug content analysis and in-vitro dissolution study of best formulation even after 6 months.
Keywords: Almotriptan, Controlled release, Dissolution profile, in-vitro drug release, Stability studies.
2. Baert L, Remon. J.P: Influence of amount of granulation liquid on the drug-release rate from pellets made by extrusion-spheronization; Int. J. Pharm; 1993; 95:135-41.
3. David M. Jones, Solution and Suspension Layering, in Pharmaceutical Pelletization Technology, ed. by Ghebre-Sellasie I., Ed. Marcel Dekker Inc., New York, 1989, 145 – 165;
4. Deasy PB, Gouldson MP. In vitro evaluation of pellets containing enteric co-precipitates of Nifedipine formed by non-aqueous spheronization. Int. J Pharm.1996; 132(1-2):131-141.
5. Saravana Kumar K, Ramesh Y, Chanukya Kumar G, Influence of Solvents on the Crystal Habit and Properties of Rofecoxib, Bulletin of Environment, Pharmacology & Life Sciences, 2011; 1(1):40-49.
6. Fielden. K.E., Newton. J.M., Rowe. R.C: The influence of lactose particle size on spheronization of extrudate processed by a ram extruder; Int. J. Pharm.; 1992; 81:205-12.
7. Sudheer M, Ramesh Y, Raghu murthy.V, Viswanatha Reddy M, Jhansi Reddy K Formulation and Evaluation of Gastroretentive Pioglitazone Floating Tablets, Journal of Pharmacy Research, 2011; 4(8):2468-2470.
8. Hellen. L, Yliruusi. J, Muttonen. E, Kristofferson. E: Process variable of the radial screen extruder: II. Size and size distributions of pellets; Pharm.Tech. Int. Biophys; 1993; 5:44–53.
9. Husson. I, Leclerc. B, Spenlehauer. G, Veillard. M, Puisieux. F, Couarraze. G: Influence of size polydispersity on drug release from coated pellets; Int. J. Pham; 1992; 86, 113-21.
10. Jacob Kristensen and Vibeke Wallaert Hanser: Wet granulation in rotary processor and fluid bed comparison granules and tablet properties; APPS pharma Sci.tech; (2006); 7 Article 22.
11. Anand Kumar. M, Dr. P. K. Lakshmi, Dr. J. Balasubramanium. Formulation, Development and In-vitro Evaluation of Tamsulosin HCl Extended Release Pellets International Journal of Pharm Tech Research April-June 2011; 3(2):968-979.
12. Ramesh Y, Raghu murthy.V, Nagarjuna S ,Viswanath Reddy M, Sudheer M, Manikanta M, Development and In vitro Evaluation of Fast dissolving Tablets of Imipramine International journal of Research in Pharmaceutical sciences, 2011; 2(3):344-347.
13. Xiaopeng Han, Linan Wang, Yinghua Sun, Xiaohong Liu, Wanjun Liu, Yuqian Du, Lin Li, Jin Sun, Preparation and evaluation of sustained-release diltiazem hydrochloride pellets, Asian journal of pharmaceutical sciences 2013; 8:244-254.
14. KL. Senthilkumar, M. Muthukumaran and B. Chenchuratnam, Formulation, and Evaluation of Rabeprazole Sodium Enteric Coated Pellets, International Journal of advances in pharmacy, Biology and chemistry, 2012; 1(1).
15. Chen Kuang, Yinghua Sun, Bing Li, Rui Fan, Jing Zhang, Yumin Yao, Zhonggui He, Preparation and evaluation of duloxetine hydrochloride enteric-coated pellets with different enteric polymers, Asian journal of pharmaceutical sciences 2017; 12:216-226.
16. Nicholas C. Obitte and Abali Sunday Okorie, Formulation development of theophylline in coated polymeric pellets for controlled oral drug delivery, The Pharma Innovation Journal 2015; 3(11):01-05.
17. P.Eswaramma, M.Vijaya kumari, G.Sruthi, V.Yamini Saraswathi, A. Naveen Kumar, G. Rajasekhar, M. Raja Rathnam. Formulation and evaluation of extended-release pellets of metoprolol succinate, IAJPS 2017; 4 (08):2308-2320.
18. Ramesh Y, Pudi Venkata Prasad, Formulation and evaluation of fast dissolving tablets of ketorolac tromethamine, Creative Journal of Pharmaceutical Research, 2(1):12-18.
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.
Authors who publish with this journal agree to the following terms:
- Authors retain copyright and grant the journal right of first publication with the work simultaneously licensed under a Creative Commons Attribution-NonCommercial 4.0 International (CC BY-NC 4.0). that allows others to share the work with an acknowledgment of the work's authorship and initial publication in this journal.
- Authors are able to enter into separate, additional contractual arrangements for the non-exclusive distribution of the journal's published version of the work (e.g., post it to an institutional repository or publish it in a book), with an acknowledgment of its initial publication in this journal.
- Authors are permitted and encouraged to post their work online (e.g., in institutional repositories or on their website) prior to and during the submission process, as it can lead to productive exchanges, as well as earlier and greater citation of published work (See The Effect of Open Access).