Formulation And Evaluation Of Captopril Sustained Release Tablet By Qbd Approach.
DOI:
https://doi.org/10.37591/rrjodfdp.v10i1.1314Keywords:
Quality By Design, Sustain Release, Captopril, Xanthan Gum, Ethyl Cellulose, Calcium Chloride.Abstract
The purpose of present study was to formulation and evaluation of Captopril sustained release tablet by QbD approach using size expanding polymer and cross linker. Captopril is a ACE inhibitor use in treatment of mild to moderate hypertension. Captopril having biological half-life of 2 hrs. The drugs gets degrade as its goes to higher pH, so we selected size expanding GRDDS. In formulation development study by using QbD, we found that the critical quality attributes affecting final drug product are swelling index, Q8 (%) and T90 (hrs). They were further categorized base in their risk level by risk assessment as high, medium and low level. After that particular control strategy apply in order to control risk and reduced level from high to low, medium to low then after justification was given for update risk assessment and optimized batch was prepared and evaluated. The three-level, three factorial Box-Behnken experimental designs was adopted. Design-Expert 8.0.7.1 was used for generating mathematical equations and inferring the statistical significance of one model over the other. The results shown that the optimized formulation containing xanthan gum (250 mg) , ethyl cellulose (70 mg) and calcium chloride (137 mg) shown the better swelling index (364.45), Q8 (38.51), and T90 (21 hrs 6 min). From results it concluded that this study demonstrated that the QBD is a potential Paradigm for understanding the quality and optimizing the formulation and process by using implementation of QBD approach.References
Schoen FJ, (2008). Disease of organ system. Robiss and cotran pathologic basis of disease, 7,525-530.
Mathur P, Saroha K, Syan N, Verma S and Kumar V. (2010). Floating drug delivery system: An innovative acceptable approach in gastroretentive drug delivery. Archives of Applied Science Research, 2 (2),257-270.
Anna NP, Tiwari S, Kamble S, (2012). Mucoadhesive As Oral Controlled Gastroretentive Drug Delivery System. International Journal of Research in Pharmacy and Science 2(3),32-59.
Anand S, Surana, And Rakhee K. Kotecha, (2010). An Overview On Various Approaches To Oral Controlled Drug Delivery System Via Gastro retention. International Journal Of Pharmaceutical Sciences Review And Research, 5, 68-72.
Shaikh S, Molvi KI, Sayyed N, (2013). Various Perspectives of Gastroretentive Drug Delivery System: A Review. American Journal of Advanced Drug Delivery. 1(4),443‐451.
Dwivedi S, and Kumar V (2011). Floating Drug Delivery Systems- A Concept of Gastro retention Dosages Form. International Journal of Research in Pharmaceutical and Biomedical Sciences, 2(4),1413-1426.
Pande SD, Pranita V. Vaidya, Gulhane PN (2013).Floating Drug Delivery System (Fdds): A New Way for Oral Drug Delivery System” International Journal of Pharmaceutical and Clinical Science, 3(1), 1-13.
Nikita Dixit, (2011). Floating Drug Delivery System Journal of Current Pharmaceutical Research.7 (1), 6-20.
Vinod KR, Vasa S, Anbuazaghan S, David B, Padmasri A, Sandhya S (2010) Approaches For Gastroretntive Drug Delivery Systems, International Journal Of Applied Biology And Pharmaceutical Technology,1(2),589-601.
Badoni I, Ojha A, Gnanarajani, Kothiyal P,(2012). Review On Gastro Retentive Drug Delivery System, The Pharma Innovation,1(8),32-42.
Mishra J, Dash A,(2013). Recent Advances In Gastro Retentive Drug Delivery System,A Review, Mintage Journal Of Pharmaceutical & Medical Sciences, 2(2),25-27.
Sarojini S, Manavalan R (2012).An overview on various approaches to Gastroretentive dosage forms, International Journal of Drug Development & Research. 4(1),1-13.
Nayak AK, Maji R, Das B, (2010). Gastroretentive drug delivery systems: A review, Asian Journal of Pharmaceutical and Clinical Research,3(1),2-10.
Sharma D, Sharma A, (2014).Gastroretentive drug delivery systems: A mini review, Asian Pacific Journal of Health Sciences,1(2),80-89.
Garg R, Gupta GD (2008). Progress in Controlled Gastroretentive Delivery Systems ,Tropical Journal of Pharmaceutical Research, 7 (3),1055-1066.
Pundir S, Badola A and Sharma D (2013). Sustain Release Matrix Technology And Recent Advances In Matrix Drug Delivery System” International Journal of Drug Research and Technology,1: 12-20.
Parashar T, Soniya, Singh V, Singh G, Tyagi S, Patel C, Gupta A,(2013).Novel Oral Sustained Release Technolog, A Concise Review, International Journal Of Research And Development In Pharmacy And Life Science, 2(2).262-269.
SampathKumar KP, Bhowmik D, Srivastava S, Paswan S, Dutta AS, (2012).Sustained Release Drug Delivery Potential, The Pharma Innovation,1(2), 46-56.
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