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Transcript
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