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Preparation and Characterization of Individual and Multi-drug Loaded Physically Entrapped Polymeric Micelles
Published on: August 28, 2015
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Methylphenidate Fast Dissolving Films: Development, Optimization Using Simplex Centroid Design and In Vitro
Biswajit Basu1, Ankur Mankad2, Ayon Dutta1
1Bengal School of Technology, Department of Pharmaceutics, West Bengal, India.
Turkish Journal of Pharmaceutical Sciences
|July 1, 2022
Summary
This study optimized methylphenidate hydrochloride mouth dissolving films (MDF) for treating attention deficit hyperactivity disorder (ADHD) and narcolepsy. The developed films offer rapid drug release and disintegration, showing promise for acute symptom management.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
- Formulation Development
Background:
- Attention deficit hyperactivity disorder (ADHD) and narcolepsy require effective and rapid-acting treatments.
- Methylphenidate hydrochloride is a key therapeutic agent for these conditions.
- Existing formulations may present challenges in acute symptom management.
Purpose of the Study:
- To design and optimize methylphenidate hydrochloride mouth dissolving films (MDF).
- To develop a fast-dissolving dosage form for acute treatment of ADHD and narcolepsy.
- To evaluate the impact of polymer composition on film properties and performance.
Main Methods:
- Solvent casting method was employed for MDF preparation.
- Simplex centroid design was used for optimization of polymers (HPMC E5, HPMC E15, maltodextrin) and drug release, disintegration, and tensile strength.
- Fourier-transform infrared spectroscopy and differential scanning calorimetry were used to assess complex formation.
- Multiple regression analysis, contour plots, and 3-D surface plots were utilized for data analysis.
Main Results:
- Polymer composition significantly influenced drug release, disintegration time, and tensile strength.
- Developed regression equations accurately predicted experimental outcomes.
- The optimized MDF demonstrated over 95% drug release within 2 minutes.
- The final formulation exhibited disintegration within one minute and possessed good tensile strength.
Conclusions:
- Methylphenidate hydrochloride MDF offers a promising alternative for treating ADHD and narcolepsy.
- The optimized formulation meets critical performance criteria for rapid drug delivery.
- MDF represents a potentially superior dosage form for acute symptom management of ADHD and narcolepsy.
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