1. Progress & Challenges in Optimizing and delivering new Paediatric products Vijay Agarwal, Macleods Pharmaceuticals

2. 2 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 Rifampicin, Isoniazid and Pyrazinamide Dispersible Tablets ( 75 + 50 + 150 ) mg Stability of Fixed dose combination Bitter taste of drugs Disintegration and dispersion to meet the compendial requirements Making bioequivalent to Single Dose Reference Products Challenges : Current Status:

3. 3 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. Rifampicin and Isoniazid Dispersible Tablets ( 75 + 50 ) mg Stability of Fixed dose combination Bitter taste of drug Disintegration and dispersion to meet the compendial requirements Making bioequivalent to Single Dose Reference products Challenges : Current Status:

4. 4 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) Isoniazid Dispersible Tablets 100 mg 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 Challenges : Current Status:

5. 5 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 Ethambutol Dispersible Tablets 100 mg 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 Challenges : Current Status:

6. 6 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) Pyrazinamide Dispersible Tablets 150 mg 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 Challenges : Current Status: