Development and Characterization of Trandolapril Immediate Release Tablets Using Different Superdisintegrating Agents
Abstract
A potent non-sulfhydryl prodrug, trandolapril is transformed into the active substance, trandolaprilat, in the liver. For obese individuals with mild-to-moderate essential hypertension, Trandolapril is effective and safe. The elimination t1/2 of trandolapril and trandolaprilat are approximately 6 hours and 16–24 hours, respectively. The goal of present work is to develop the Trandolapril immediate release tablet using various superdisintegrants. Crospovidone, Sodium starch glycolate and Croscarmellose sodium in concentrations of 2%, 4%, and 6% were used as superdisintegrating agents for the optimization. Direct compression technique was used to make nine formulations (IRTR 1 to IRTR 9). The powder blends of all batches were evaluated for different parameters to know the powder flow characteristics and it was found that the powder blend had excellent flow and compressibility characteristics. Then, compressed tablets were tested for quality control parameters as per the IP. In formulation IRTR1-IRTR9, disintegration time was observed 30.23 to 71.67 Sec and more than 70% drug was released in 30 min. Thus, based on evaluation results, it is concluded that formulation of immediate release (IR) tablets of Trandolapril were successfully developed. Minimum disintegration time 30.23 seconds 90.56% drug release in 30 min was obtained with IRTR3.
References
2. Peters DC, Noble S, Plosker GL. Trandolapril: An update of its pharmacology and therapeutic use in cardiovascular disorders. Drugs. 1998 Nov; 56: 871-93.
3. Benet LZ, Broccatelli F, Oprea TI. BDDCS applied to over 900 drugs. The AAPS journal. 2011; 13: 519-47.
4. Zannad F. Trandolapril: how does it differ from other angiotensin converting enzyme inhibitors? Drugs. 1993; 46(2): 172-82.
5. https://pubchem.ncbi.nlm.nih.gov/compound/Trandolapril (accessed on 21.2.23).
6. Sharma N, Pahuja S, Sharma N. Immediate release tablets: A review. Int. J. Pharm. Sci. Res. 2019; 11: 3607-18.
7. Karim S, Bosu A, Biswas A, Laboni FR, Julie AS and Rashid MHO. Effect of sodium starch glycolate on the formulation of Fexofenadine hydrochloride immediate release tablets by direct compression method. Journal of Scientific Research 2018; 10(1): 31-38.
8. Sharma AR, Shrivastava B, Bhargava A, Sharma S, Raina B, Bajwa PS. Design development and optimization of immediate release tablet of valsartan. Journal of Drug Delivery and Therapeutics. 2019; 9(2):43-7.
9. Suzuki Y, Sugiyama H, Kano M, Shimono R, Shimada G, Furukawa R, Mano E, Motoyama K, Koide T, Matsui Y, Kurasaki K. Control strategy and methods for continuous direct compression processes. Asian Journal of Pharmaceutical Sciences. 2021; 16(2): 253-62.
10. Bansal M, Bansal S, Garg G. Formulation and evaluation of immediate release tablets of zaltoprofen. Scholars Acad J Pharm. 2013; 2: 398-405.
11. Sharma SN and Sonawane RS: Role of superdisintegrants in immediate release tablets: a review. Journal of Pharmaceutical and BioSciences 2017; 5(1): 1-5.
12. Roumeli E, Tsiapranta A, Pavlidou E, Vourlias G, Kachrimanis K, Bikiaris D, Chrissafis K. Compatibility study between trandolapril and natural excipients used in solid dosage forms. Journal of thermal analysis and calorimetry. 2013; 111: 2109-15.
13. Maruti MS, Shirsat MK. Development and Designing Trandolapril Topical Film for Management of Cardiac Stroke. Journal of Advanced Scientific Research. 2022 Feb 28; 13(01): 294-304.
14. Lacmann L, Libermann AH and Joseph LK. The theory and practice of Industrial pharmacy. 3rd Indian ed. Vargese publishing House, Bombay (1991) :185-188.
15. Aulton EM. Aulton’s Pharmaceutics; The Design and Manufacturer of Medicines. 3rd ed. Churchill Livingstone (2007) :338-339.
16. Indian pharmacopoeia. Volume 1. Government of India Ministry of Health & Family Welfare, Indian Pharmacopoeia Commission. Ghaziabad (2007) :177-183
.