Drug Delivery Technologies

Orally Disintegrating Tablets		      
         
 
Benefits for patients
Traditional tablets and capsules administered with a glass of water may be inconvenient for some patients:
 

•  a woman travelling and suffering from a migraine attack may not have immediate access to a glass of water,
•  a schizophrenic patient can hide a conventional tablet under his tongue to avoid his daily dose of antipsychotic,
•  a patient undergoing radiation therapy may be too nauseous to swallow his anti-nausea treatment
•  an elderly patient may not be able to swallow a daily dose of anti-Parkinson treatment,
•  a child with allergies could use a more convenient dosage form than an antihistamine syrup.

         
 
Orodis® tablets are a perfect fit for all of these patients as they rapidly disintegrate in the saliva without the need for water. The ease of administration of Orodis® tablets may encourage a patient to adhere to a daily medication regimen.
 
         
 
Benefits for pharmaceutical companies
The market success of Orally Disintegrating Tablets is evident. There are about 40 products presented in this dosage form in therapeutic areas as varied as schizophrenia, migraine, nausea, pain, allergies, Parkinson disease, Alzheimer disease, diarrheas...
For pharmaceutical companies, this dosage form offers the following advantages:
 

•  Lifecycle Management : re-formulation is a strategy to prolong market exclusivity as it may delay or reduce generic erosion at patent expiry.
•  Differentiation in a crowded market
•  Line extension
•  For generic companies it offer the prospect of superior generic drugs in order to gain market dominance upon the expiration of patents
•  Cost Effective Drug Development

   
         
  Orodis® Technology      
         
 
There are several technologies to consider for Orally Disintegrating Tablets. Orodis® is a compressed technology, beside a fast disintegration time in the mouth (15 to 30 seconds) it has many advantages against other technologies:
 

•  Hard tablets, not fragile - Easy to handle
•  No specific packaging required, can be packaged in push-through blisters
•  Smooth moothfeel
•  Pleasant taste - incorporation of taste masking agents and flavours
•  All the materials meets USP and EP standards
•  Conventional manufacturing equipment - Not difficult to transfer to the final production site
•  Cost effective

         
 

Taste masking
Active ingredients often have an unpleasant taste (e.g. bitter, astringent or metallic). To succeed in the market with an ODT, taste masking or taste modification is crucial. Our development team has a wide experience in term of taste masking/taste modification. The flavours and sweeteners are used not only to disguise the unpleasant taste of the active substance, but also to create a pleasant taste experience that increases patient satisfaction and compliance.

   
         
 
Collaboration steps for Orodis® technology  
   
Physica Pharma has a step-by-step approach as described below:
 
   

1. Feasibility study

The objective is to develop formulation prototype(s ) having best possible specifications: disintegration, dissolution, hardness, friability, taste.
   

3. Development phase

If the client is satisfied with the prototypes produced during the feasibility study, the company enters into a development agreement. Physica Pharma proposes a development plan in line with the specific requirements related to Orally Disintegrating Tablet with the aim to prepare a technical dossier for the submission of a Marketing Authorization Application.