ABSTRACT:
The Enteric Capsule Drug Delivery Technology (ECDDT) was designed to enable oral administration while ensuring complete enteric protection and swift release in the upper gastrointestinal (GI) tract, without the need for coatings. Current study used a 32factorial design (Stat-Ease Design Expert v12) to formulate a mini-tablet in an enteric-coated capsule to treat ulcerative colitis utilising ECDDT and mini-tablets. Mesalamine, an amino salicylate, was used as a model drug to study the effects of independent variables like HPMC K4M as a release retarding polymer at 10-20% and Crospovidone as a super disintegrant at 2-5% on in vitro drug release to meet desired Q points of dissolution. higher value of Tmax (10 Hours) and T1/2 (9 Hours) was observed for the Optimized formulation with Cmax value of (35.24 ± 0.45 ng/mL), AUC (0-48) (411.58 ± 1.45 hr.ng/mL) and Ke (0.077 ± 0.010 hr-1) it may be due to delayed release formulation.
Cite this article:
Donepudi Pradyumna, Lankalapalli Srinivas, Nallamothu Krishna. Formulation and evaluation of Mesalamine mini-tablets in enteric-coated capsule for the treatment of ulcerative colitis using a factorial design approach. Research Journal of Pharmacy and Technology.2024; 17(8):4035-2. doi: 10.52711/0974-360X.2024.00626
Cite(Electronic):
Donepudi Pradyumna, Lankalapalli Srinivas, Nallamothu Krishna. Formulation and evaluation of Mesalamine mini-tablets in enteric-coated capsule for the treatment of ulcerative colitis using a factorial design approach. Research Journal of Pharmacy and Technology.2024; 17(8):4035-2. doi: 10.52711/0974-360X.2024.00626 Available on: https://rjptonline.org/AbstractView.aspx?PID=2024-17-8-74
REFERENCES:
1. Meher JG, Singh Y, Chaurasia M, Reddy BS, Chourasia MK. Targeting of gastrointestinal tract for amended delivery of protein/peptide therapeutics: Strategies and industrial perspectives. Int J Pharm. 2014; 196: 168-183.
2. Choonara BF, Choonara YE, Kumar P, Bijukumar D, du Toit LC and Pillay VA. Review of advanced oral drug delivery technologies facilitating the protection and absorption of protein and peptide molecules. Biotechnology Advances. 2014; 32: 1269-1282.
3. Raymond CR, Paul J Sheskey and Marian EQ. Handbook of pharmaceutical excipients; 6th edition. 2009.
4. Gold G, Duvall RN and Palermo BT. New instrumentation for determining flexure breaking strength of capsule-shaped tablets. J Pharm Sci. 1980; 69(4): 384-386.
5. Fell JT, Newton JM. Determination of tablet strength by the diametral-compression test. J Pharm Sci. 1970; 59(5): 688-691.
6. Stanley P and Newton JM. The tensile fracture stress of capsule-shaped tablets. J Pharm Pharmacol. 1980; 32(12): 852-854.
7. Pitt KG, Newton JM and Stanley P. Tensile fracture of doubly-convex cylindrical discs under diametral loading. J Mater Sci 1988; 23; 2723-2728.
8. Juan Qin, Xin Di, Xin Wang and Youping Liu. Development and validation of an LC-MS/MS method for the determination of Mesalazine in beagle dog plasma and its application to a pharmacokinetic study. Biomed Chromatogr. 2015; 29(2): 261-267.
9. USFDA (2003): Guidance for Industry: Bioavailability and bioequivalence studies for orally administered drug products-General considerations.