5.1. LAMOTRIGINE
5.1.1. Drug profile
• Drug name : Lamotrigine
• Chemical name: 6-(2,3-dichloro phenyl) -1,2,4-triazine-3,5-Damine
• Proprietary name: Lamictal, LTG, BW-430C
• Category: Anti epileptic activity
• Formulae: Empirical formulae: C9H7Cl2N5 Molecular weight: 256.09 Structural formulae:
5.1.2 Physical Characteristics:
Table 5.1: Details of the drug
S. No Parameter Observation 1 Description White to pale cream color powder 2 BCS Class II 3 Solubility Very slightly soluble in water and Slightly soluble in anhydrous ethanol 4 Melting point 216oC-218 oC 5 PKa…show more content… Properties: Physical Appearance : White powder Particle Size : 2 - 7 microns Bulk Density : 176 - 208 kg/m3 pH (1% water dispersion): 2.5 - 3.0 Moisture Content : < 2% Equivalent Weight : 76 ± 4 Solubility : Soluble in dilute acid solutions, insoluble in alkaline solution, water and most organic solvents. 5.2.2.4.Regulatory Acceptance
Included in the FDA Inactive Ingredients Guide (oral suspensions, tablets; ophthalmic, rectal, and topical preparations transdermal preparations, vaginal suppositories). Included in non-parenteral medicines licensed in Europe. Included in the Canadian list of Acceptable Non-medicinal Ingredients. Table 5.4. Application of carbopol with reference to IIG limits
s.no Category Concentration range
1 Controlled release polymer 5-30
2 Emulsifier 0.1-0.5
3 Gelling agent 0.5-1
4 Suspending agent 0.5-1
5 Tablet binder