Biopharmaceutics Lab
Report
Lab: Dissolution of
mefenamic acid
Prepared by
Sozy Jalal F190165
Aro Alan F180012
Bahast Aso F190462
Shaima Taymoor F180286
Shko Hussein F180149
Prepared for:
Dr. Kotaiah Silakabattini
Date:
14th Dec 2022
Aim:
To find out the dissolution rate for mefenamic acid
Introduction:
Dissolution is generally defined as a process by which a solid substance
is solubilized into the solvent to yield a solution. Drug dissolution
characteristic is an important quality parameter to ensure in vivo
performance of solid drug products, especially for generic drug products
since the drug absorption process from solid dosage forms (especially
for drugs given by oral route) depends on the release of the drug
substance from the drug product, the dissolution or solubilization of the
drug under physiological conditions, and the permeability across the
gastrointestinal tract. Because of the critical nature of the first two
mentioned steps, in vitro dissolution may be relevant to the prediction of
in vivo performance.
Mefenamic acid [2-[(2,3-dimethylphenyl)amino]benzoic acid], an
anthranilic acid derivative, is a non-steroidal anti-inflammatory drug
(NSAID) which is widely used to relief mild to moderate pain. Mefenamic
acid is classified as class II on the basis of biopharmaceutical
classification system (BCS). It has low water solubility but high
permeability. The absolute bioavailability of this drug is about 90–100%.
For BCS class II drugs, the dissolution process is critical in ensuring high
or acceptable drug absorption
Methods
• Basket
• UnitedStatesPharmacopoeia (USPApparatusI)
• Padddle – UnitedStatesPharmacopoeia (USPApparatusII)
• Reciprocating cylinder
• United StatesPharmacopoeia(USPApparatus3)
USP provides the dissolution test of mefenamic acid solid dosage form
only for capsule. In this test, USP urges the application of type 1 (basket)
dissolution test apparatus set at rotation speed of 100 rpm, using 900
mL tris buffer at pH 6.8 containing
Methods:
• Basket
• UnitedStatesPharmacopoeia (USPApparatusI)
• Padddle – UnitedStatesPharmacopoeia (USPApparatusII)
• Reciprocating cylinder
• United StatesPharmacopoeia(USPApparatus3)
PROCEDURE:
1.
Transfer the required stated amount of dissolution medium free from
dissolved air into a vessel of apparatus by maintaining dissolution
medium temperature between 36.50C – 37.50C.
2. Place one individual tablet in individual containers and tablet was
observed to reach the bottom of the vessel, prior to start the apparatus.
3. In the time interval specified, sample was withdrawn from the zone
midway between the surface of dissolution medium and top of rotating
blade, not less than 10mm from wall of vessel.
4. Add a volume of dissolution medium equal to that of withdrawn
sample volume to maintain the sink condition. Repeat the procedure for
6 or more times till the last interval of dissolution studies.
5. For each tablet tested individually, calculate the amount of dissolved
active ingredient in the solution as % of stated amount.
6. If one or two tablets fail to disintegrate completely, repeat the test on
12 additional tablets. The requirement is met if not less than 16 of the
total of 18 tablets tested are disintegrated.
Results: