FORMULATION AND IN VITRO CHARACTERIZATION OF METOCLOPRAMIDE LOZENGES BY USING THE QUALITY BY DESIGN (QBD) APPROACH

Muhammad Abid Mustafa; Aiman Mahmood; Seerat Shahzad; Nayyab Kanwal; Namra Rasheed; Mahgull Mahmood; Umair Amjad; Muhammad Ahmed Saeed; Muhammad Shahmir Ahsan; Shehzada Muhammad Afaq Raza; Muhammad Haris Pervaiz; Raza Hanif; Rania Ahmad

doi:10.22270/ujpr.v9i3.1111

Muhammad Abid Mustafa Department of Pharmaceutics, Faculty of Pharmaceutical Sciences, Lahore University of Biological & Applied Sciences, Lahore, Pakistan.
Aiman Mahmood Punjab University College of Pharmacy, University of the Punjab, Lahore, Pakistan. Minhaj University, Lahore, Pakistan.
Seerat Shahzad Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Lahore University of Biological & Applied Sciences, Lahore, Pakistan.
Nayyab Kanwal Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Lahore University of Biological & Applied Sciences, Lahore, Pakistan.
Namra Rasheed Department of Pharmaceutics, Faculty of Pharmaceutical Sciences, Lahore University of Biological & Applied Sciences, Lahore.
Mahgull Mahmood Department of Pharmaceutics, Faculty of Pharmaceutical Sciences, Lahore University of Biological & Applied Sciences, Lahore.
Umair Amjad Department of Pharmaceutics, Faculty of Pharmaceutical Sciences, Lahore University of Biological & Applied Sciences, Lahore.
Muhammad Ahmed Saeed Department of Pharmaceutics, Faculty of Pharmaceutical Sciences, Lahore University of Biological & Applied Sciences, Lahore.
Muhammad Shahmir Ahsan Department of Pharmaceutics, Faculty of Pharmaceutical Sciences, Lahore University of Biological & Applied Sciences, Lahore.
Shehzada Muhammad Afaq Raza Department of Pharmaceutics, Faculty of Pharmaceutical Sciences, Lahore University of Biological & Applied Sciences, Lahore.
Muhammad Haris Pervaiz Department of Pharmaceutics, Faculty of Pharmaceutical Sciences, Lahore University of Biological & Applied Sciences, Lahore.
Raza Hanif Department of Pharmaceutics, Faculty of Pharmaceutical Sciences, Lahore University of Biological & Applied Sciences, Lahore.
Rania Ahmad Department of Pharmaceutics, Faculty of Pharmaceutical Sciences, Lahore University of Biological & Applied Sciences, Lahore.

10.22270/ujpr.v9i3.1111

Keywords:

Design expert, metoclopramide lozenges, optimized formulation, QbD approach, response surface methodology

Abstract

Objective: Conventional dosage forms may not be suitable for all patients, especially those facing difficulty with swallowing, which results in reduced adherence to medication, impacting treatment outcomes. This study aimed to formulate and characterize metoclopramide lozenges using the quality-by-design approach to provide a patient-friendly alternative.

Materials and Method: Formulations were optimized using response surface methodology and a Design Expert, focusing on Metoclopramide, Citric Acid, and Carboxymethyl Cellulose, with hardness and dissolution as primary response variables. The experimental design involved 20 runs, six replications of the central point, and a quadratic model for improved model fitting, with adjustments made through transformation and numerical hill-climbing algorithms.

Results and Discussion: Formulations of metoclopramide lozenges were obtained through a systematic quality-by-design approach. Using numerical optimization, the formulation with the highest desirability score of 1.00 was selected, yielding a hardness of 14.55 kg and a dissolution time of 1.25 minutes. The optimal coded values were 1.53223 grams for Metoclopramide (A), 4.84302 grams for Citric acid (B), and 18.5048 grams for Carboxymethyl cellulose (C). The optimized formulation was subjected to in vitro testing to validate its performance, yielding a hardness ranging from 13.98 to 15.00 kg/cm² and a dissolution time ranging from 1.11 to 2.23 minutes. The effectiveness of the QbD approach was confirmed as outcomes closely aligned with the targeted responses.

Conclusions: The Quality by Design approach was found effective in optimizing the formulation of metoclopramide lozenges. Using the Design of Expert and Response Surface Methodology, an optimized formulation was obtained with the desired hardness and dissolution rate.