Perception of Tolperisone as a Muscle Relaxant and to find right fit for the combination of Tolperisone,

Diclofenac and Paracetamol.

By:-Rajat patelSummer Intern

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Muscle spasm and spasticity• Muscle spasm is sudden involuntary contraction of a

muscle.• Due to injury, imbalance in electrolytes or spinal cord

injury• Spasticity is caused by an imbalance between muscle

contraction and relaxation process• Due to Spinal cord injury, multiple sclerosis, cerebral

palsy, brain damage, head injury.

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Tolperisone (Tolfree)

• Recently launched in October 2008 in India.• For treatment of acute and chronic back pain

and spasticity neurological disorder.• M/A:- Blockade of Sodium and Calcium

Channel• Presynaptic –inhibition

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Positioning of Tolperisone(tolfree)

• Freedom from sedation.• Selective muscle relaxant.• Analgesic effect.• Good safety profile(Good GI tolerability and

no drug interaction with benzodiazepines and NSAIDs)

• Dose dependant muscle relaxant.

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Tolfree

• Product description:- Tolperisone Hydrochloride Tablets:-100/150 mg.

• Indications:o Myalgiao Sprains and Strainso Post Traumatic Injuryo Rehabilitation Program

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Objective of study• To study the perception of Tolperisone

hydrochloride vis a vis other muscle relaxant.– To validate that whether it has been perceived by the

doctors the way it has been communicated?– What are the doctor’s view of Tolperisone as a muscle

relaxant?– Which are the other muscle relaxants preferred by

different specialty of doctors?• To find right fit for the combination of

Tolperisone, Diclofenac and Paracetamol.– Whether the combination of Tolperisone, Diclofenac and

Paracetamol feasible or not according to the doctor.– If it is feasible than how and where would we place it.

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Research Methodoloy

• Research methodology needed is descriptive research.

• Because we need to find out the questions like Which doctors are using what kind of muscle relaxants, when are they using them and that will help us segment and target markets.

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SECONDARY DATA• INTERNAL:• Sales records.• Competitor’s analysis.

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Continue…• EXTERNAL:• ORG-IMS & C marc data• Drug Index.• Websites.• Journals.• Study materials.

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Sample design

• Here the variability with in the sample to be observed will be very less.

• Here our target population mainly are Orthopaedics followed by Neuro, General practitioner and Consultant Physician.

• Here the sample were mainly from the different parts of the city of Ahmedabad.

• We can extrapolate the results to the entire population.

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Sample distribution

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Results

Q-1 How often in a week do you prescribe muscle relaxants?

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Results(cont.)

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Results(cont.)

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results(cont.)Q-2 In which indications you prescribe muscle

relaxants?

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Results(cont.)

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Results(cont.)

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Results(cont.)• Q-3 which molecules do you prefer as a muscle

relaxant?

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Results(cont.)

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Results(cont.)

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Results(cont.)

• Q-4 If you have prescribed tolperisone then in which indication?

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Results(cont.)

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Results(cont.)

Q-5 how would you rate tolperison on the following criteria vis a vis other muscle relaxants?

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Results(cont.)• Q-6 If you have not tried or not using

Tolperisone kindly share the reason for the same.

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Results(cont.)

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Results(cont.)

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Results(cont.)• Q-7 which analgesics do you prefer along with

the muscle relaxants?

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Results(cont.)

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Results(cont.)

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Q-8 If the combination of tolperisone comes with diclofenac and paracetamol would you like to prescribe it?

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Results(continue)

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Results(cont.)

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Factors that doctor consider before prescribing muscle relaxant

• efficacy• Rapid onset of action• Analgesic effect• Safety profile• Price

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Feasibility with diclofenac and paracetamol

• Diclofenac is well established one of the oldest molecules with most clinical trials supporting its efficacy.

• Tried and tested molecule preferred by all the category of doctors.

• Side effect is very low with only gastric irritation in the hypersensitive patients

• Diclofenac and paracetamol is among the better tolerated NSAIDs. Though 20% of patients on long-term treatment experience side effects, only 2% have to discontinue the drug, mostly due to gastrointestinal complaints.

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Continue…• The half life of diclofenac and Paracetamol is

around 1.2-2 hours and 3-4 hours respectively which matches with the half life of tolperisone which is around 1.5-2.5 Hours so both are feasible with tolperisone pharmacokinetically.

• Easy to market the diclofenac and paracetamol to the GPs as these are their most preferred NSAIDs.

• Other NSAIDs like nimesulide and coxibs like celecoxib and refecoxibs are selective cox-2 inhibitors which has led to increased incidence of adverse cardiovascular events according to clinical trials

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Continue…• Because of these results, some molecules were

withdrawn from the market (Rofecoxib, September 2004 and Valdecoxib, April 2005). In addition, the FDA and EMEA (USA and European Community Health Authorities respectively) started a revision process of the entire class of COX-2 inhibitors.

• As being observed in some localities retailers give NSAIDs by themselves and they mainly prefer diclofenac in combination with muscle relaxant for e.g. Den MR and Powergesic

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Comments/Suggestions• Majority of the doctors(70-75 % of them) especially

in acute to subacute condition prefer combination of muscle relaxants with analgesics or NSAIDs.

• Tolperisone is not effective in curbing the pain as compare to other centrally acting muscle relaxants like Chlorzoxazone, Tizanidine and Thiocolchicoside as per the doctors.

• Frequent dosage can also be one of the factors for doctors not prescribing the drug

• So can introduce sustain release dosage form.(Especially in spasticity of neurological disorders where drug with Long half-life is suitable)

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Comments/Suggestions• Freedom from sedation positioning can be

useful in subacute to chronic indications of myalgia spasm and spasticity but in case of acute situations like trauma, injury where bed rest is advised doctors don’t mind muscle relaxant having sedative effect.

• Drug has been mainly used for LBP of acute to chronic condition so it should be positioned in LBP also.

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Comments/Suggestions

• Drug has not been communicated well as found that most of the GPs were not aware of it and in other categories also either doctors were not aware of it or have not tried it yet.

• But the encouraging fact is that those who are using it are quite satisfied with its efficacy, safety profile and its characteristic of not causing sedation.

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Positioning

• We can position the Combination drug in severe LBP from acute to subacute to even chronic indication.

• In fibromyalgia of acute indication• In spasticity involving post stroke and multiple sclerosis • Rehabilitation program, post traumatic injury.• Because of the good safety profile in children it can be

very useful in the patient of cerebral palsy where Diazepam and Tizanidine is being used.

• Spinal pain (spondylitis, lumber pain)

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Prepared by:- Rajat PatelGuided by :-Mr. Ram subramaniam.Co- guide :-Mr. Jaydeep shriyan.

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