Transcript Vijay Agarwal`s presentation

Progress & Challenges in
Optimizing and delivering new
Paediatric products
Vijay Agarwal,
Macleods Pharmaceuticals
Rifampicin, Isoniazid and Pyrazinamide
Dispersible Tablets ( 75 + 50 + 150 ) mg
Challenges :
•
Stability of Fixed dose combination
•
Bitter taste of drugs
•
Disintegration and dispersion to meet the compendial requirements
•
Making bioequivalent to Single Dose Reference Products
Current Status:
•
3 months 40°C/75% stability data in PVC/PVdC/PE amber Blister, PVC/PVdC amber blister and Alu strip pack are found
satisfactory.
•
Excipients compatibility samples under analysis
•
Disintegration Time : 20 to 30 seconds
•
‘Fineness of Dispersion’ complies
•
‘Taste’ is good.( with Strawberry flavour)
•
BE study under way
2
Rifampicin and Isoniazid Dispersible Tablets
( 75 + 50 ) mg
Challenges :
•
Stability of Fixed dose combination
•
Bitter taste of drug
•
Disintegration and dispersion to meet the compendial requirements
•
Making bioequivalent to Single Dose Reference products
Current Status:
•
3 months 40°C/75% stability data in PVC/PVdC/PE amber Blister, PVC/PVdC amber blister and Alu strip pack are found
satisfactory.
•
Excipients compatibility study done
•
Disintegration Time : 20 to 30 seconds
•
‘Fineness of Dispersion’ complies
•
‘Taste’ is good.( with Raspberry flavour)
•
BE study done.
3
Isoniazid Dispersible Tablets 100 mg
Challenges :
•
Bitter drug
•
Selection of excipients particularly flavour is very critical to avoid interaction
•
Disintegration and dispersion to meet the compendial requirements
•
Making bioequivalent to Reference Drug
•
Divisibility (Uniformity of Subdivision) compliance
Current Status:
•
2 months 40°C/75% stability sample in Alu strip pack is under analysis, result awaited.
•
Excipients compatibility samples under analysis
•
Disintegration Time : 20 to 30 seconds
•
‘Fineness of Dispersion’ complies
•
Divisibility (Uniformity of Subdivision) under analysis
•
‘Taste’ is good.( with Raspberry flavour)
4
Ethambutol Dispersible Tablets 100 mg
Challenges :
•
Freely soluble and highly hygroscopic drug causing disintegration problem
•
Selection of excipients particularly flavour is very critical to avoid interaction
•
Bitter drug
•
Disintegration and dispersion to meet the compendial requirements
•
Making bioequivalent to Reference Product
Current Status:
•
12 months stability data available
•
Excipients compatibility samples under analysis
•
Disintegration Time less than 1 minute
•
‘Fineness of Dispersion’ complies
•
‘Taste’ is good
•
Pivotal BE study underway
5
Pyrazinamide Dispersible Tablets 150 mg
Challenges :
•
Freely soluble and highly hygroscopic drug causing disintegration problem
•
Selection of excipients particularly flavour is very critical to avoid interaction
•
Bitter drug
•
Disintegration and dispersion to meet the compendial requirements
•
Making bioequivalent to Reference Product
Current Status:
•
1 months 40°C/75% stability sample in Alu strip pack is under analysis, result awaited.
•
Excipients compatibility samples under analysis
•
Disintegration Time : 1 to 2 minutes
•
‘Fineness of Dispersion’ complies
•
‘Taste’ is good.( with Orange flavour)
6