Author(s): Hardik B. Rana, Mukesh C. Gohel, Mansi S. Dholakia, Tejal R. Gandh, Abdelwahab Omri, Vaishali T. Thakkar

Email(s): hardikrana1439@gmail.com

DOI: 10.5958/0974-360X.2018.00892.2   

Address: Hardik B. Rana1*, Mukesh C. Gohel1, Mansi S. Dholakia1, Tejal R. Gandhi1, Abdelwahab Omri2, Vaishali T. Thakkar2
1Department of Pharmaceutics, Anand Pharmacy College, Anand - 388 001, Gujarat, India.
2The Novel Drug and Vaccine Delivery Systems Facility, Department of Chemistry and Biochemistry, Laurentian University , Sudbury, ON , Canada
*Corresponding Author

Published In:   Volume - 11,      Issue - 11,     Year - 2018


ABSTRACT:
Objective: The present research aims to integrate the concept of quality by design (QbD) to develop galantamine HBr modified release pellets and to scrutinize the critical factors that can affect the quality of the pellets prepared by extrusion spheronization technique. Materials and Methods: Modified release pellets of galantamine HBr were prepared using Compritol 888 ATO and ethyl cellulose (EC) as release retardants. Avicel pH 101 was selected as an extruder aid. Before converting the wet extrudates in pellets, pregelatinized starch was sprinkled on them to improve the physical properties of the pellets. Qualitative risk analysis was performed to screen and identify the significant factors using Failure Mode Effect Analysis (FMEA) model. Central composite design was adopted to optimize the formulation. Concentration of Compritol and concentration of ethyl cellulose were selected as independent factors and drug release at 2, 6, and 10 h were selected as dependent variables. The pellets were evaluated for size, shape, flow, % yield, % friability and drug content. Results and Discussion: Concentration of Compritol and concentration of EC were found to be critical factors from FMEA model. All the batches of central composite design showed excellent flowability, spherical shape, desired size, yield, friability and drug content. Multiple linear regression analysis and analysis of variance were performed to identify the effect of independent variables on different responses. Design space was generated from the data. In vivo plasma concentration time profile was predicted from in vitro data. Conclusion: Concentration of Compritol and EC were found to be significant for the development of modified release pellets. Innovative finding of the present research is to explore the potential use of pregelatinized starch as a dry binder in the post wet extrusion step.


Cite this article:
Hardik B. Rana, Mukesh C. Gohel, Mansi S. Dholakia, Tejal R. Gandh, Abdelwahab Omri, Vaishali T. Thakkar. Development of Sustained Release Pellets of Galantamine HBr by Extrusion Spheronization Technique Incorporating Risk based QbD Approach. Research J. Pharm. and Tech 2018; 11(11): 4899-4910. doi: 10.5958/0974-360X.2018.00892.2


Recomonded Articles:

Author(s): R. Narayana Charyulu, P. Parvathy Devi, Jobin Jose, A. Veena Shetty

DOI: Not Available         Access: Open Access Read More

Author(s): Archana Kushwaha, Jayanti Jaiswal, Priya Singh, Neha Rathore, Jai Prakash Dhruw, Ishu Sahu, Chhaya Singh, Krinsha Kumar Sahu, Mukta Agrawal, D. K. Tripathi, Ajazuddin, Amit Alexander

DOI: 10.5958/0974-360X.2017.00270.0         Access: Open Access Read More

Author(s): Ravi K. Barde, Minal R. Narkhede, V.R. Gudsoorkar, Rahul K. Amrutkar, Prashant S. Walke

DOI: Not Available         Access: Open Access Read More

Author(s): Vaseeha Banu T.S., Sandhya K.V., K.N. Jayaveera

DOI: Not Available         Access: Open Access Read More

Author(s): N. Chandarsekaran, M. Balamurugan

DOI: Not Available         Access: Open Access Read More

Author(s): Karthikeyan D, Vijayakumar S, Pandey V.P, Nandha Kumar J, Sengottuvelu S, T. Sivakumar T.

DOI:         Access: Open Access Read More

Author(s): Mohammed Ehtesham Ur Rahman, Mohammed Abdul Haseeb, Mohammed Saleem, Abdul Naveed

DOI: Not Available         Access: Open Access Read More

Author(s): Gupalli Laxmi Narasimha, Dappu Jairam, Akkenapally Krishna, Mohammed Rehan Qureshi

DOI: 10.5958/0974-360X.2015.00025.6         Access: Open Access Read More

Author(s): Zain Mhanna, Wehad Ibrahim, Tamim Hammad

DOI: 10.5958/0974-360X.2016.00040.8         Access: Open Access Read More

Author(s): P Kumar, R Tiwari, B Chaurasia, RR Sahu, FM Tripathi, Anjana Bhardhwaj

DOI: Not Available         Access: Open Access Read More

Author(s): Suresh V Kulkarni, Ranjit Kumar P, Nikunj Patel, Ramesh B, Someshwara Rao B, Ashok Kumar P

DOI: Not Available         Access: Open Access Read More

Author(s): M.A. Saleem, Raghavendra V. Kulkurni, Patil Noornadim G

DOI: Not Available         Access: Open Access Read More

Author(s): Pavani M., D.P. Mastan Yadav, Manikanta Kumar A., K.S. Manjunath Shetty

DOI: Not Available         Access: Open Access Read More

Author(s): Maushumi Kulkarni, Rahul Thube, Kiran Bhise, Mohammed Kakajiwala

DOI: Not Available         Access: Open Access Read More

Author(s): Venkateswaramurthy N, Sambathkumar R, Vijayabaskaran M, Perumal P

DOI: Not Available         Access: Open Access Read More

Author(s): Ramesh V Shinde, Pawar Jaydip B, Kadam Sagar D, Landge Dhananjay A, Rahul Ahirrao, Kulkarni Vaishali , Patil VG, Pawar Gitanjali R

DOI: Not Available         Access: Open Access Read More

Author(s): Annapurna Uppala, Naga Swapna V, Neelima Devi R, Glory Sheren G, Kishore Kumar B

DOI: 10.5958/0974-360X.2015.00230.9         Access: Open Access Read More

Author(s): V.V. Nageswara Rao, K.V. Ramana Murthy

DOI: Not Available         Access: Open Access Read More

Research Journal of Pharmacy and Technology (RJPT) is an international, peer-reviewed, multidisciplinary journal.... Read more >>>

RNI: CHHENG00387/33/1/2008-TC                     
DOI: 10.5958/0974-360X 

0.38
2018CiteScore
 
56th percentile
Powered by  Scopus


SCImago Journal & Country Rank


Recent Articles




Tags