TD: Orodispersible Technologies

Question 1

What are oral dispersable tablets?

Answer 1

• Dosage forms which are taken orally and disperse in the oral cavity. The resulting ‘suspension’ or ‘solution’ will then be swallowed.
• They are not swallowed whole and they are not buccal or effervescent tablets.
• Made with materials and processes which allow rapid dispersion in the oral cavity.

Question 2

Why are oral dispersible tables useful?

Answer 2

• Useful for patients with dysphagia:
  
  • Parkinson’s disease.
  • AIDS
  • thyroidectomy.
  • head & neck radiation therapy
  • renal failure
• Paediatric & geriatric patients.
  
  • Patients smaller therefore more swallowing issues
• Patients who are reluctant to take their medication – psychiatric patients.
  
  • Hide in cheeks but these will dissolve
• Patients who are busy.
  
  • Not have to carry water around
• Patients who do not access to clean water

Question 3

What are the ideal characteristics of an ODT?

Answer 3

• Rapid disintegration.
• Good mechanical strength.
• Appropriate tablet size.
• Taste and mouth feel suitable.
• Stable.
• Fast disintegration (swellability) or fast dissolution.
• Minimal residue in oral cavity.
• No adverse effect to efficacy of active.
• Low cost!!!!!!!!!

Question 4

Limitations of ODT

Answer 4

1. Drug loading
   
   1. lyophilisation process
   2. soluble drugs max 60mg,
   3. insoluble max 400mg.
2. Taste masking
3. Problems with bitter drugs.
4. Limitation of drug choice
   
   • Cannot be used for drugs with short half-life and frequent dosing.
5. Advanced delivery systems
   
   • Cannot be used for controlled or sustained release.
6. Bioequivalence
   
   • BA may be different to that of non-ODT products due to pre-gastric absorption and in some cases avoidance of First Pass Metabolism.

Question 5

What methods of manufacturing are there?

Answer 5

Question 6

Describe the manufacturing process of ODT by direct compression

What excipients are required?

Answer 6

• API and excipents mixed and compressed - compression is gentle and excipients used are rapidly distigrating or dissolving.
• Method of orodispersability – fast melting ingredients or rapidly swelling of disintegrants or effervescence.
• Excipients – diluent, disintegrant, flavour, sweetener, lubricant, (effervescent agent, colourant).

Question 7

Describe the manufacturing process of ODT using the candyfloss manufacturing method.

What excipients are used?

What are the advantages?

Answer 7

Method

• 80% saccharide with 1% surfactant mixed then formed into ‘floss’ fibres (using Candy Floss process) which are amorphous.
• Chopped and conditioned using ethanol in a High Shear Granulator.
• Floss particles are then blended with drug and other excipients and finally tableted.

Excipients

• Excipients-
• Sugars and polymaltodextrins and polydextrose form floss.
• Surfactants (1%w/w) to act as crystalline enhancers.
• Drug and other tabletting excipients.

Advantages

• Structural strength improved by further conditioning at 40°C & 85% RH.
• Higher doses can be incorporated.

Question 8

Describe the manufacturing process of producing ODT using the spray drying method

Answer 8

Mannitol - rapidly dissolving sugar

Question 9

Describe the manufacturing process of ODT by an effervescent formulation

Answer 9

Question 10

escribe the manufacturing process of ODT by fast dissolving film formulation

Answer 10

Question 11

Describe the manufacturing process of ODT in terms of moulding

Answer 11

Question 12

Advantages and disadvantages of ODT

Answer 12