5.1Preformulation studiesDeterminationof some physical and chemical properties of drug and excipients through the is required in thedevelopment of dosage forms.Preformulation is defined as a critical step in research and development process where thephysicochemical properties of drug andexcipients used are characterized in order to formulate stable and effectivedosage forms.5.1.1API characterization and identificationPiroxicam(API) was procured from Hetero labs Hyderabad. as gift sample. Identificationof drug was carried out by various pharmacopoeial guidelines.
I.Organoleptic propertiesColourand odour of API were characterized and recorded using terminology.II.SolubilitySolubilityof piroxicam in different solvents was studied. The solubility of piroxicam wastested in various solvents.IV.Melting pointMeltingpoint of piroxicam was determined using melting point apparatus. Test wascarried out by taking a small amount of APIin a capillary tube with one end closed and placed in melting point apparatus.
The melting point was tested in triplicate.V.Loss on drying 3gms of piroxicam was taken in glass plate andkept in an hot air oven. Temperature was set at1050Cand the powder was weighed to constant weight. Distribute the sample evenly as practicable bygentle shaking to a depth not crossing 10 mm.
Place the LOD bottle in the oven at 105°c by for 4 hours. After drying iscompleted, open the oven, close the crucible and allow it to cool at room temperature indesiccator for 30 minutes. Weigh the crucible and calculate the percentage LOD.CalculationWeightof empty crucible = W1Weightof crucible + sample = W2Weightof sample = W2-W1Weightof crucible + sample after drying = W3Lossin Weight of sample after drying = W2-W3LOD(% w/w) = (W2 – W3) /(W2 – W1)x 100