Author(s):
Shubham P. Bhadane, Rajendra K. Surawase
Email(s):
sbhadane46@gmail.com
DOI:
10.52711/0975-4377.2025.00026 
Address:
Shubham P. Bhadane, Rajendra K. Surawase
Loknete, Dr. J. D. Pawar, College of Pharmacy, Manur, Shivaji Nagar, Kalwan, Tal. Kalwan, Dist. Nashik. 423501.
*Corresponding Author
Published In:
Volume - 17,
Issue - 3,
Year - 2025
ABSTRACT:
Ambroxol hydrochloride is a potent mucolytic agent capable of inducing bronchial secretions used in the treatment of respiratory disorders linked to thick or viscous mucus. The Sustained release matrix tablets containing 75 mg Ambroxol hydrochloride were developed using different drug: polymer ratios. Sustained release matrix tablets were prepared by direct compression method. evaluated for loose bulk density, tapped bulk density, compressibility index and angle of repose, shows satisfactory results. The prepared tablets were further evaluated for uniformity of weight, hardness, friability, thickness, content uniformity, In-vitro dissolution, drug-excipients interactions, swelling index study also carried out. The FT-IR studies revealed that there was no chemical interaction between drug and excipients. In-vitro release studies were carried out using USP type II (paddle method) dissolution apparatus at 50 rpm. The absorbance of these solutions was identified at 250 nm using a UV Spectrophotometer. Among all formulations, the preparation of the F4 batch showed the highest percent drug release at 98.56% after 12 hours. end of 12 h. The stability studies were carried out according to ICH guideline, which indicates that the selected formulations were stable.
Cite this article:
Shubham P. Bhadane, Rajendra K. Surawase. Formulation and Development of Sustained Release Matrix Tablets of Ambroxol hydrochloride by QBD Approach. Research Journal of Pharmaceutical Dosage Forms and Technology.2025; 17(3):183-0. doi: 10.52711/0975-4377.2025.00026
Cite(Electronic):
Shubham P. Bhadane, Rajendra K. Surawase. Formulation and Development of Sustained Release Matrix Tablets of Ambroxol hydrochloride by QBD Approach. Research Journal of Pharmaceutical Dosage Forms and Technology.2025; 17(3):183-0. doi: 10.52711/0975-4377.2025.00026 Available on: https://rjpdft.com/AbstractView.aspx?PID=2025-17-3-4
REFERENCES:
1. Dilip M. Kumbhar, Vijay D. Havaldar, Kailas K. Mali, Remeth J. Dias, Vishwajeet S. Ghorpade, Rahul B. Londhe. Formulation and Evaluation of Sustained Release Tablets of Venlafaxine Hydrochloride for the treatment of Depressive disorders. Asian J. Pharm. Res. 2017; 7(1): 8-14.
2. SC Basak, BM Jayakumar Reddy, KP Lucas Mani, Formulation and release behaviour of sustained release ambroxol hydrochloride HPMC matrix tablet. Indian Jurnal of Pharmaceutical sciences 2006; 68: 594-598
3. Dhananjay M. Formulation, Development, and Evaluation of Sustained Release Tablet of Ambroxol Hydrochloride Asian Journal of Pharmaceutics (AJP). 16(4). https://doi.org/10.22377/ajp.v16i4.4603.
4. Nilesh V. Ingle Preparation and Evaluation of Ambroxol Hydrochloride Matrix Tablet using different Combination of Polymers. Int. J. PharmTech Res. 2011; 3(1).
5. S. Jayaprakash, S. Vimal Kumar, Balmukund R. Rathi, M. Nagarajan. Effect of Hydrophilic Matrix on The Release Behavior of Ambroxol Hydrochloride. International Journal of PharmTech Research.
6. Raparla Ramakrishna Et al. Development and Evaluation of Ambroxol Hydrochloride Sustained Release Tablets Using Hpmc as Polymer. Journal of Global Pharma Technology. 2009; 1(1): 88-93
7. Mayuri B. Patil, Avish D. Maru, Jayshree S. Bhadane. Formulation and Evaluation of Sustained Release Bilayer Matrix Tablet of Glimepiride and Metformin Hydrochloride. Asian Journal of Research in Pharmaceutical Sciences. 2021; 11(4):
8. Abhijeet U. Bankar, Vidyadhar H. Bankar, Preeti D. Gaikwad, Sunil P. Pawar. Formulation Design and Optimization of Sustained Release Tablet of Ambroxol hydrochloride International Journal of Drug Delivery. 2012; 4: 375-385 http://www.arjournals.org/index.php/ijdd/index
9. Montgomery DC. Design and analysis of experiments. John Wiley and Sons. 2017.
10. Box GE, Hunter JS, Hunter WG. Statistics for experimenters. In Wiley Series in Probability and Statistics. 2005.
11. Hoboken, NJ: Wiley. Robinson JR, Lee VHL. Controlled Drug Delivery: Fundamentals and Applications, 2nd ed. New York, Marcel Dekker, Inc.1987.
12. Brahmankar DM, Jaiswal SB. Textbook of Biopharmaceutics and pharmacokinetics. Vallabh Prakashan, Delhi, Edition. 1995; 1: 337-41.
13. Lachmann 1, Lieberman H.A. The Theory and Practice of lodustrial Pharmacy, Varghese Publishing House, Mumbai, 3rd Edition. 1987: 430431.
14. Dr. Y. Krishna Reddy, K. Akhila. Extended-Release Matrix Tablets of Nateglinide: Formulation and In vitro Evaluation. Asian J. Pharm. Res. 2020; 10(2): 101-104.
15. K, Rangasamy M. Formulation and evaluation of sustained release tablets of aceclofenac using hydrophilic matrix system. International Journal of PharmTech Research. 2010: 1775-1780
16. Agarwal G, Agarwal S, Karar PK, Goyal S. Oral sustained release tablets: an overview with a special emphasis on matrix tablet. Am J Adv Drug Deliv. 2017; 5(2): 64-76.
17. T. E. Gopala Krishna Murthy, V. Akash. Development of Metoprolol Tartrate Sustained Release Formulations by using Modified Starches. Asian J. Res. Pharm. Sci. 2018; 8(4): 241-246
18. Sunil Kumar, B. Someswara Rao and Suresh V. Kulkarni Department of Pharmacy, Sree Siddaganga College of Pharmacy, Tumkur IJPSR. 2014; 5(10): 4225-4232
19. Hemul V. Patel et. al. Journal of Scientific and Innovative Research. 2013; 2(2): 271.
20. Ratnaparkhi MP, Gupta Jyoti P. Sustained release oral drug delivery system-an overview. Terminology. 2013; 3(4): 10-22270
21. Koundrourellis J.E., Eleftheria T.M., Theodora A.B. High performance liquid chromatographic determination of ambroxol hydrochloride in the presence of different preservatives in pharmaceutical formulations. J. Pharm. Biomed. Anal. 2000; 23: 469-475.