Abstract
Aim
The present work was aimed to formulate and optimize fast dissolving thin strips of Desvenlafaxine Hydrochloride using QbD.
Materials and Methods
The solvent casting method was used to formulate fast dissolving thin strips. The drug (Desvenlafaxine HCl), polymer
(pullulan), super disintegrant (Croscarmellose sodium), plasticizer (Poly Ethylene Glycol-(PEG-400), saliva stimulating agent (citric acid), sweetening agent (mannitol and aspartame) and water (solvent) were used in the preparation of the strips. The study involved a 3-level factorial design in which the effect of Pullulan Polymer (A), Croscarmellose Sodium (B) and Poly Ethylene Glycol (C) on 3 response variables disintegration Time (X), percent swelling index (Y) and percent Dissolution Efficiency (DE%15) were analyzed.
Results
From the studies, it was found that F12 formulation (containing 30% pullulan, 5% CCS and 7.5% PEG) was the optimized formulation that showed improved important strip characteristics including disintegration time, swelling index and dissolution efficiency after 15 min.
Introduction
The oral route is the 1st choice for most patients for the administration of therapeutic agents.1 In the market, approximately 60% of solid oral dosage forms are accessible in various forms such as tablets and capsules.2 According to estimates, 30-40% of elderly individuals suffer from dysphasia.3 Fast dissolving thin strips appear as an alternative technique to deliver the drug among pediatrics and geriatrics. The Fast-Dissolving Thin Strips (FDTS) are better than Fast Disintegrating Tablets (FDTs), which are connected with choking and friability issues. It can be easily used for dysphasic and schizophrenic patients and can be taken without water. For the formulation of FDTSs, many procedures are used; the most common are solvent casting and spraying methods. Hydrophilic polymers are commonly used in the preparation of FDTS, which allow strips to dissolve fast, releasing the Active Pharmaceutical Ingredient (API) within seconds.4,5
Desvenlafaxine HCl is selective serotonin and nor-epinephrine reuptake inhibitor and is used to treat depressive disorders in adults. As per Biopharmaceutical Drug Disposition Classification System (BDDCS) Desvenlafaxine is a class 3 drug (high solubility, poor metabolism, low permeability) while as per Biopharmaceutics Classification System (BCS), it is class 1 (high solubility, high permeability) compound which makes it a suitable candidate for FDTS. The current research aimed to develop and optimize fast dissolving thin strips of Desvenlafaxine HCl for ease of administration, patient compliance and can be easily given to pediatrics and geriatrics. It also offers the advantage of bypassing hepatic metabolism, resulting in increased bioavailability of drugs. The basic objective of the study was to formulate and evaluate fast dissolving thins strips of Desvenlafaxine HCl by Quality by Design. For the fabrication of strips, pullulan, cross carmellose, Polyethylene glycol was used. The strip was prepared by solvent casting method.
Once the strips were prepared, it was evaluated for pH, folding endurance, moisture uptake, swelling index, disintegration time and dissolution efficiency. The effect of pullulan, croscarmellose sodium and PEG-400 on disintegration time, swelling index and dissolution efficiency was determined by contour plot and response surface plot.6
Download the full article as PDF here Formulation and Optimization of Fast Dissolving Thin Strips of Desvenlafaxine HCl by Using Quality by Design (QbD) Approach
Materials
Desvenlafaxine was procured as a pure drug from Balaji Drugs in Mumbai, India. Central Drug House Ltd., New Delhi, supplied pullulan, croscarmellose sodium and polyethylene glycol. The excipients and reagents used in the study were of analytical quality. Quality Target Product Profile (QTPP) for Fast Dissolving Thin Strips (FDTSs) of Desvenlafaxine QTPP as specified by the International Council for Harmonization (ICH) Q8 is an important component of a QbD strategy. The QTPP includes all product attributes essential to assure equal safety and efficacy of the product.
Ganesh Kumar, Meenakshi Bhatt, Archana Dhyani, Formulation and Optimization of Fast Dissolving Thin Strips of Desvenlafaxine HCl by Using Quality by Design (QbD) Approach, Indian Journal of Pharmaceutical Education and Research, Vol 59, Issue 3, Jul-Sep, 2025, DOI: 10.5530/ijper.20255095, Copyright Information: Copyright Author (s) 2025 Distributed under Creative Commons CC-BY 4.0, Publishing Partner : Manuscript Technomedia.
