4. DRUG AND EXCIPIENT PROFILE
4.1 DRUG PROFILE (Oxybutynin chloride)60,61,62,63
A. Molecular Weight: 393.96
B. Chemical Formula: C22H31NO3 • HCl
C. Melting point: 124 – 129°C.
D. Description: White crystalline, practically odourless powder.
E. Solubility: Freely soluble in water and in alcohol; very soluble in methanol and in chloroform; soluble in acetone; slightly soluble in ether; very slightly soluble in hexane.
F. IUPAC Name: Benzeneacetic acid, α-cyclohexyl-α-hydroxy,-4-(diethylamino)-2-butynyl ester hydrochloride, (±)-4-(diethylamino)-2-butynyl- α-phenylcyclohexane glycolate hydrochloride.
G. Functional categories: Anticholinergic and Antispasmodics
H. Structural formula: Figure 14: Chemical structure of OXB
I. PKa: 8.04
Anticholinergic agents are those which block the neurotransmitter…show more content… Also act as a binder in tablet
8) Applications in pharmaceutical formulation
Lactose is widely used as a filler or diluent in tablets and capsules, and to a more limited extent in lyophilized products and infant formulas. Lactose is also used as a diluent in dry-powder inhalation. Other applications of lactose include use in lyophilized products, where lactose is added to freeze-dried solutions to increase plug size and aid cohesion.
9) Pharmacopoeial Specifications
a. Density (true):1.545 g/cm3 (-lactose monohydrate)
b. Melting point: 201–202°C (for dehydrated -lactose monohydrate)
c. Solubility: Soluble in water
10) Stability and Storage Conditions: Mold growth may occur under humid conditions (80% relative humidity and above). Lactose may develop a brown coloration on storage, the reaction being accelerated by warm, damp conditions. The purities of different lactoses can vary and colour evaluation may be important, particularly if white tablets are being