Development and Characterisation of Fast Dissolving Oral Films


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Pardeep Kumar Jangra

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Development and Characterisation of Fast Dissolving Oral Films

  1. 1. Submitted To: Mrs. Rajni Bala (Asst. Professor) Rayat Institute of Pharmacy Presented By: Pardeep Kumar Jangra M.Pharm. (Pharmaceutics) Roll No. - 1265351
  2. 2. Introduction Special Features Advantages Over Tablets Drug Profile Formulation Composition Marketed Formulations of Thiocolchicoside Disadvantages of Thiocolchicoside Marketed Formulations Advantages of Thiocolchicoside FDOF over Marketed Formulations Method of Preparation Plan of Work
  3. 3. Fast dissolving oral film (FDOF) is an advanced drug delivery system, it consists of a thin film when placed on patient’s tongue or mucosal tissue film gets wet by saliva and dissolves within few seconds releasing the drug for oral absorption. It is prepared from hydrophilic polymers which disintegrate rapidly upon hydration. It was first developed in 1970’s as an alternate to tablets and capsules.
  4. 4. Thin elegant film Available in various sizes & shapes Non-obstructive Fast disintegration and rapid drug release Self administration is possible Excellent mucoadhesion
  5. 5. Fast Dissolving Film Tablet Large surface area gives greater dissolution. Less surface area gives less dissolution than FDOF. Films are flexible and durable. Tablets are brittle and less durable than films. No risk of chocking. It has a fear of choking. More patient compliance. Less patient compliance. No need of water for administration. Need water for administration. Reduction in first pass metabolism. No such advantage over films. Faster onset of action. Slower onset of action.
  6. 6. Proprietary Name: IUPAC Name: Appearance: Bioavailability: Half Life: Route: Dose: Solubility: UV Range: Category: Thioact, Thiofast, Thiorelax, Colchico, Myoside. N-[(7S)-3-(beta-D-glucopyranosyloxy)-1,2dimethoxy-10-(methylsulfanyl)-9-oxo-5,6,7,9tetrahydrobenzo[a]heptalen-7-yl]acetamide Yellow or pale yellow crystalline powder. 25% 5-6 hours. Oral, topical, parenteral. 4-8mg. Water soluble (16.1mg/ml), less alcohol soluble. 264.5 - 254.5nm Muscle relaxant, anti inflammatory, analgesic.
  7. 7. Sr. No. Ingredient Quantity(w/w) Example 1. Drug 5-30% Thiocolchicoside 2. Film Forming Polymer 40-50% HPMC E3, E5, E15 (Synthetic) Pullulan, Xanthan Gum, Pectin, Gelatin (Natural) 3. Plasticizer 0-20% Propylene Glycol, Glycerin, Sorbitol 4. Sweetening Agent 3-6% Mannitol, Sucrose, Sorbitol 5. Saliva Stimulating Agent 2-6% Citric Acid, Ascorbic Acid 6. Surfactant q.s. Sod. Lauryl Sulfate, Tween 7. Flavouring Agent q.s. Menthol, Lemon Oil 8. Colors, Filler etc. q.s. Titanium Dioxide, Mannitol
  8. 8. Sr. No. Brand Name Manufacturer Dosage Form Quantity/unit 1. Thioceclo SR Aristo Pharm. Pvt. Ltd. Tablet 8 mg 2. Thiospas Piramal Healthcare Capsule 4, 8 mg 3. Zyflex Inj. 4mg Zydus Synovia Injection 2mg/ml 4. Myoril Inj. 4mg Sanofi Aventis Injection 2mg/ml 5. Thioact Sun Pharma. Capsule 4, 8mg 6. MuscoRil Sanofi Aventis Ointment 30gm 7. Thioquest Alchem Int. Ltd. Tablet 4, 8 mg
  9. 9. DISADVANTAGES OF THIOCOLCHICOSIDE TABLETS: 1. Low bioavailability due to first pass effect. 2. Slower onset of action as compared to FDOF. 3. Risk of choking or obstruction. DISADVANTAGES OF THIOCOLCHICOSIDE OINMENT: 1. Application of exact quantity of ointment to the affected area is difficult. 2. It is less stable dosage form. 3. It can be used only for local action. DISADVANTAGES OF THIOCOLCHICOSIDE INJECTION: 1. Self administration is difficult. 2. It cause pain during administration. 3. They are expensive and manufacturing require greater precautions.
  10. 10. Increased drug bioavailability as first pass metabolism effect is reduced. Faster onset of action as drug is directly absorbed in systemic circulation through oral mucosal epithelium. No need of water during administration. Self administration is possible. No fear of obstruction. Stable dosage form. Uniform quantity of drug can be incorporated in FDOF. No pain on administration like injection. Cheaper dosage form.
  11. 11. Generally “Solvent Casting” method is used for the preparation of FDOF. Solvent/water or suitable mixture of solvents Add Excipients Heating upto 60oc Stirring at 1000 rpm Solution Add Polymer Cooling at room temperature Replenishing of evaporated solvent Stirring at 1000 rpm Add Drug/API Replenishing of evaporated solvent Final Film Solution Drying at 60oc Casting/Defoaming Polymer Film
  12. 12. Phase 1: Literature survey, procurement of drugs and excipients Phase 2: Preformulation studies of drug and excipients Organoleptic properties Solubility M.P. (Melting Point apparatus and DSC studies) Determination of absorption maxima for analysis Drug excipient compatibility studies FTIR Analysis Phase 3: Formulation of mouth dissolving oral strips Phase 4: Characterization of mouth dissolving oral strips Organoleptic evaluation Thickness Dryness testtack tests Tensile strength Percent elongation Tear resistance Folding endurance Disintegration time Dissolution time Assaydrug content and content uniformity Phase 5: Compilation of data and submission of thesis