Metoprolol Tartrate Essay

MATERIALS AND METHODS
Metoprolol Tartrate was obtained as a gift sample from IPCA Pharmaceuticals Ltd, Mumbai. HPMC K-4M, HPMC K-15M and Eudragit RL-100 were obtained from Colorcon Pvt. Ltd Goa. Glycerol was obtained from Nice Chemicals Pvt. Ltd Kochi. Acetone, Ethylcellulose, Ethanol, Sodium Saccharin and Dibutyl Phthalate were obtained from SD Fine Chemicals Pvt. Ltd.Mumbai.
Preformulation studies
Melting point of Metoprolol tartarte was determined by capillary tube method for checking the authentication of drug.
Compatibility of the Metoprolol Tartrate with polymers and excipients was established by infrared spectral analysis. IR spectral analysis of sample (Metoprolol tartrate, polymers, and a mixture of the drug with each of the polymer)

The samples were placed in aluminium pans and were crimped, followed by heating under nitrogen flow at a scanning rate of 5oC / min from 30oC to 300oC. Empty pan was used as reference. The heat flow as a function of temperature was measured for both drug-polymer mixture and drug.
Solubility Analysis
Solubility analysis was done, which included the selection of suitable solvent to dissolve the drug. The solubility study of polymers in different solvents was also carried out.

Formulation of Metoprolol Tartrate Buccal patches
Calculation of amount of Metoprolol Tartrate for one circular cast Patch:
• Internal diameter of the petridish= 9cm

• Internal Radius of the petridish = 4.5 cm

• Internal surface Area of the petridish = πr2 =3.14 × (4.5 )2 =63.585 cm2
• Size of one buccal Patch = 2 cm × 2 cm = 4 cm 2
• Area of the buccal patch = πr2 =3.14 × (1)2 =3.14cm2
• Amount of drug to be present in 3.14 cm2 of patch is 50 mg ,then
• Amount of drug to be added to the 63.585 cm2 area of the petridish is = 63.585 × 50 ÷ 3.14 = 1012.5 mg
• Dose of the drug per patch = 50

Then add 120 ml of diluent and sonicate for 5 minutes. Make up the volume with Methanol and mix well. Filter this solution through 0.45 µm membrane filter. (0.25 mg/ml) PLACEBO PREPARATION:
Weigh accurately an amount of Placebo powder which is equivalent to 50 mg of Metoprolol Tartrate into 200 mL volumetric flask, add 10 ml of water and sonicate for about 10 minutes with intermittent shaking. Then add 120 ml of methanol and sonicate for 5 minutes. Make up to the volume with methanol and mix well. Filter this solution through 0.45 µm membrane filter.(0.25 mg/ml). INSTRUMENTATION AND ANALYSIS CONDITIONS The HPLC analysis was performed on waters alliance using PDA detector. The separation was carried out using Hypersil BDS C-18 (150×4.6mm, 3µ) conditions. The mobile phase composition of mixture of buffer and acetonitrile (80:20)was selected for the separation. Analysis was carried out at a flow rate of 1.0ml/min with a detection wavelength 280nm and the injection volume was set at 10µL. Isocratic pump mode was used and an ambient temperature was