This document presents a proposal for a master's project on developing and evaluating fast dissolving oral films containing melatonin. The project aims to create an improved oral delivery system for melatonin that provides a fast onset of action and is more convenient for elderly patients compared to traditional dosage forms. The methodology will involve preparing film formulations using different polymers and plasticizers via solvent casting. The films will be tested for characteristics like thickness, strength, disintegration time, and dissolution profile to identify the optimal formulation. Potential difficulties involve achieving the proper film consistency and high API loading. The conclusions will report the best polymer and plasticizer concentrations identified for a melatonin oral film with rapid sleep induction.

1. Presentation of Proposal form
of master
By
Muhanad omer taher
Pharmaceutics department

2. CONTENTS
• Introduction
• Hypothesis and goals
• Methodology (materials, methods, evaluation tests)
• Scope and limits to the research
• Conclusions

3. INTRODUCTION
Fast dissolving oral films
• a novel trend to oral drug delivery
• were first introduced in the 1970s as an alternative to pills, capsules, and
syrups for pediatric and geriatric patients who had trouble swallowing
standard oral solid-dosage formulations.
• is a solid dosage form that dissolves or disintegrates in approx. 1 minute
when put in the mouth without water or chewing making them particularly
suitable for all types of patients.

4. AIM(S) OF STUDY
 To develop, preparation and evaluation of a new form of melatonin
as a fast dissolving oral films.
 To provide Fast onset of action, and rapid sleep induction of
melatonin oral films as compared to conventional oral solid dosage
forms.
 Rapid migraine pain relief.
 To achieve Better compliance for elderly patients.

5. OBJECTIVES
 Finding the best concentration for each of the polymers to form a film with
acceptable thickness and strength to withstand handling.
 Comparing the film forming capacity of various polymers.
 Finding the best concentration of each of the plasticizers that can give enough
elasticity to the films with each of the selected polymers.
 Successfully incorporating API into the best formula.

6. METHODOLOGY
MATERIALS
• Film forming polymer:
• HPMC K15, NaCMC, CMC, HPC, combination of HPMC and NaCMC
• Plasticizer:
• Glycerol, PEG 400
• Saliva stimulating agent:
• Citric acid
• Sweetening agent
• Sodium sacharine

7. METHOD OF FILM PREPARATION
• Solvent casting method
Due to several Advantages:
 Simple
 Applicable and ease of processing.
 Greater thickness consistency and clarity than extrusion.
 The films feature a high gloss finish and are devoid of flaws such as die lines.
 Films have better physical qualities and are more flexible.

9. CHARACTERIZATION AND EVALUATION TESTS
• Visual inspection
• Thickness test
• Folding endurance
• Content uniformity
• Weight variation
• Disintegration and dissolution tests.

10. SCOPE AND LIMIT TO THE RESEARCH
Scopes are to be as follows:
• Difficulties during preparation of film.
• Difficulty in achieving the ideal film with proper consistency.
• Time consuming due to finding the best polymer and ideal concentrations.
Limitations to the research:
• Incorporation of high doses of API and other ingredients.
• Incompatibility of API and ingredients.

11. CONCLUSIONS
• A new form of melatonin oral strips will be prepared with rapid
onset of sleep induction.
• Best polymer of film forming that will compatible with API and
provide better consistency to the film.
• The research conclude that the best concentration of plasticizer
will be provided.