For My review article on Fast Dissolving Oral Films, click on this link http://www.ijupbs.com/Uploads/2.%20RPA13140283015.pdf or copy paste this link in browser. Pardeep Kumar Jangra

1. Submitted To:
Mrs. Rajni Bala
(Asst. Professor)
Rayat Institute of Pharmacy
Presented By:
Pardeep Kumar Jangra
M.Pharm. (Pharmaceutics)
Roll No. - 1265351

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. 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. Thin
elegant film
Available in various sizes & shapes
Non-obstructive
Fast disintegration and rapid drug release
Self administration is possible
Excellent mucoadhesion

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. 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. 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. 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. 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. 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. 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. 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