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ISSN (Print): 2210-299X
ISSN (Online): 2210-3007

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Research Article

Design, Development, and In vitro Evaluation of Single Unit Hydrodynamically Balanced System of Captopril

Author(s): Shashank Soni* and Deepankar Bahuguna

Volume 1, 2023

Published on: 11 October, 2023

Article ID: e080823219530 Pages: 15

DOI: 10.2174/2210299X01666230808152133

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Abstract

Background: This study investigated the use of in situ polyelectrolyte complex formation by using two oppositely charged polysaccharides [Chitosan (cationic), Sodium Alginate (anionic)]. It forms 3-D intercalation and interpenetrating network helping in controlling the release of highly acid-soluble Captopril.

Objective: To develop a polyelectrolyte complex based single unit gastroretentive tablet by using optimization based 3 (2) Taguchi factorial design for controlled delivery of Captopril.

Materials and Methods: Gastroretentive Captopril tablets were prepared by the direct compression technique. Total 09 batches were prepared as per 3 (2) Taguchi factorial design studies of 100 tablets each.

Results: Thermal analysis method revealed that there is a formation of PEC between chitosan and sodium alginate. In vitro buoyancy and T60%, drug release studies revealed that due to complex formation, formulation remains stable and remains buoyant. From factorial design studies, it was interpreted that for buoyancy time (Y1) chitosan desired effect value was found higher. For 60% drug release (T60%; Y2) both chitosan and sodium alginate have a synergistic effect. Durbin Watson's statistical model and residual data suggested that the model is statistically validated. All formulations follow the zero-order kinetics. Stability studies revealed that formulations F5 and F9 remain stable for long-term stability studies without showing any significant changes. The fit analysis studies indicated that the prepared formulation was different from the innovator product indicating low f1 and f2 values.

Conclusion: From the result generated it was concluded that chitosan-sodium alginate polyelectrolyte complex has sufficient potential to retard the release of CPT.

[1]
Tripathi, K.D. Essentials of Medical Pharmacology. JP Medical Ltd, 2018; pp. 483-484.
[2]
Sathish, D.; Himabindu, S.; Kumar, P.; Rao, Y. Preparation and evaluation of novel expandable drug delivery system with captopril. Curr. Drug Ther., 2014, 8(3), 206-214.
[http://dx.doi.org/10.2174/1574885508666131203001213]
[3]
Shanthi, C.N.; Gupta, R.; Mahato, A.K. A review on captopril oral sustained/controlled release formulations. Int. J. Drug Dev. Res., 2010, 2, 257-267.
[4]
Ahsan, M.; Abbas, N.; Hussain, A.; Saeed, H.; Akhtar Shah, P.; Mohammad, S.; Arshad, M.S. Formulation optimization and in-vitro evaluation of oral floating captopril matrix tablets using factorial design. Trop. J. Pharm. Res., 2015, 14(10), 1737-1748.
[http://dx.doi.org/10.4314/tjpr.v14i10.2]
[5]
Namdev, A.; Jain, D. Floating drug delivery systems: An emerging trend for the treatment of peptic ulcer. Curr. Drug Deliv., 2019, 16(10), 874-886.
[http://dx.doi.org/10.2174/1567201816666191018163519] [PMID: 31894738]
[6]
Yang, X.; Wang, B.; Qiao, C.; Li, Z.; Li, Y.; Xu, C.; Li, T. Molecular interactions in N-[(2-hydroxyl)-propyl-3-trimethyl ammonium] chitosan chloride-sodium alginate polyelectrolyte complexes. Food Hydrocoll., 2020, 100, 105400.
[http://dx.doi.org/10.1016/j.foodhyd.2019.105400]
[7]
Jiang, Y.; Wang, Y.; Li, Q.; Yu, C.; Chu, W. Natural polymer-based stimuli-responsive hydrogels. Curr. Med. Chem., 2020, 27(16), 2631-2657.
[http://dx.doi.org/10.2174/0929867326666191122144916] [PMID: 31755377]
[8]
Soni, S.; Ram, V.; Verma, A. 3 (2) factorial design assisted crushed puffed rice-HPMC-chitosan based hydrodynamically balanced system of metoprolol succinate. Drug Deliv. Lett., 2020, 10(3), 237-249. [DOI: 10.2174/2210303110999200408122629].
[http://dx.doi.org/10.2174/2210303110999200408122629]
[9]
Lal, N.; Dubey, J.; Gaur, P.; Verma, N.; Verma, A. Chitosan based in situ forming polyelectrolyte complexes: A potential sustained drug delivery polymeric carrier for high dose drugs. Mater. Sci. Eng. C, 2017, 79, 491-498.
[http://dx.doi.org/10.1016/j.msec.2017.05.051] [PMID: 28629045]
[10]
Jagdale, S.C.; Randhave, A.B. Hydroxyl ethyl cellulose hhx and polymethyl methacrylate based site specific floating delivery of prochlorperazine maleate. Open Pharm. Sci. J., 2016, 3(1), 149-163.
[http://dx.doi.org/10.2174/1874844901603010149]
[11]
Kumar, L.; Sreenivasa Reddy, M.; Managuli, R.S.; Pai K, G. Full factorial design for optimization, development and validation of HPLC method to determine valsartan in nanoparticles. Saudi Pharm. J., 2015, 23(5), 549-555.
[http://dx.doi.org/10.1016/j.jsps.2015.02.001] [PMID: 26594122]
[12]
Durbin, J.; Watson, G.S. Testing for serial correlation in least squares regression. III. Biometrika, 1971, 58(1), 1-9.
[http://dx.doi.org/10.2307/2334313]
[13]
Khan, H.; Ali, M.; Ahuja, A.; Ali, J. Stability testing of pharmaceutical products: Comparison of stability testing guidelines. Curr. Pharm. Anal., 2010, 6(2), 142-150.
[http://dx.doi.org/10.2174/157341210791202627]
[14]
Costa, P. An alternative method to the evaluation of similarity factor in dissolution testing. Int. J. Pharm., 2001, 220(1-2), 77-83.
[http://dx.doi.org/10.1016/S0378-5173(01)00651-2] [PMID: 11376969]
[15]
Guidance, F.D. Guidance for industry: Dissolution testing of immediate release solid oral dosage forms. us department of health and human services. food and drug administration, center for drug evaluation and research. CDER, 1997.
[16]
Morais, J.A.; Lobato, M. The new EMEA guideline on the investigation of bioequivalence. Portuguese J. Pharma., 2009, 1, 76-80.
[17]
Barends, D.; Dressman, J.; Hubbard, J.; Junginger, H.; Patnaik, R.; Polli, J.; Stavchansky, S. Multisource (generic) Pharmaceutical Products: Guidelines on Registration Requirements to Establish., 2005,
[18]
Permeabilidad, C.S.; Alta, I.A.; Alta, I.B.; Baja, I.A.; Baja, I.B. National Administration of Medicines, Food and Medical Technology (ANMAT). Provision No. 3185; Buenos Aires: Argentina, 1999.
[19]
Vasiliu, S.; Racovita, S.; Popa, M.; Ochiuz, L.; Peptu, C.A. Chitosan-based polyelectrolyte complex hydrogels for biomedical applications. In cellulose-based superabsorbent hydrogels polymers and polymeric composites: A reference series Mondal M (ed.). Springer Cham, 2019; pp. 1695-25.
[http://dx.doi.org/10.1007/978-3-319-77830-3_56]
[20]
Pharmacopeia US. National Formulary (USP-25/NF-20). InRockville. United States Pharmacopeial Convention: MD, 2000.
[21]
Das, U.; Wadhwa, P.; Singh, P.K.; Kalidindi, D.V.; Nagpal, K. The role of polymers and excipients for better gastric retention of captopril. Crit. Rev. Ther. Drug Carr., 2022, 39(6), 85-106.
[http://dx.doi.org/10.1615/CritRevTherDrugCarrierSyst.2022042122]
[22]
Anaizi, N.H.; Swenson, C. Instability of aqueous captopril solutions. Am. J. Hosp. Pharm., 1993, 50(3), 486-488.
[PMID: 8442468]
[23]
Patel, P.; Dand, N.; Somwanshi, A.; Kadam, V.J.; Hirlekar, R.S. Design and evaluation of a sustained release gastroretentive dosage form of captopril: A technical note. AAPS PharmSciTech, 2008, 9(3), 836-839.
[http://dx.doi.org/10.1208/s12249-008-9120-2] [PMID: 18626773]
[24]
Abdalrb, G.A.; Mircioiu, I.; Amzoiu, M.; Belu, I.; Anuta, V. In Vitro and In Vivo evaluation of different solid dosage forms containing captopril. Curr. Health Sci. J., 2017, 43(3), 214-219.
[PMID: 30595878]

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