Development and Characterisation of Fast Dissolving Oral Films
Mrs. Rajni Bala
Rayat Institute of Pharmacy
Pardeep Kumar Jangra
Roll No. - 1265351
Advantages Over Tablets
Marketed Formulations of Thiocolchicoside
Disadvantages of Thiocolchicoside Marketed
Advantages of Thiocolchicoside FDOF over Marketed
Method of Preparation
Plan of Work
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.
Available in various sizes & shapes
Fast disintegration and rapid drug release
Self administration is possible
Fast Dissolving Film
Large surface area gives greater
Less surface area gives less
dissolution than FDOF.
Films are flexible and durable.
Tablets are brittle and less durable
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.
Thioact, Thiofast, Thiorelax, Colchico, Myoside.
Yellow or pale yellow crystalline powder.
Oral, topical, parenteral.
Water soluble (16.1mg/ml), less alcohol soluble.
264.5 - 254.5nm
Muscle relaxant, anti inflammatory, analgesic.
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
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
drug bioavailability as first pass metabolism effect is
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.
Generally “Solvent Casting” method is used for the preparation of FDOF.
Solvent/water or suitable
mixture of solvents
Heating upto 60oc
Stirring at 1000 rpm
Cooling at room
Stirring at 1000 rpm
Final Film Solution
Drying at 60oc
Phase 1: Literature survey, procurement of drugs and excipients
Phase 2: Preformulation studies of drug and excipients
M.P. (Melting Point apparatus and DSC studies)
Determination of absorption maxima for analysis
Drug excipient compatibility studies
Phase 3: Formulation of mouth dissolving oral strips
Phase 4: Characterization of mouth dissolving oral strips
Dryness testtack tests
Assaydrug content and content uniformity
Phase 5: Compilation of data and submission of thesis