Essay On Aceclofenac

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SELECTION OF DRUG
Aceclofenac is a non-steroidal anti-inflammatory drug, widely used in the management of osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. Usual therapeutic dose is 100 mg twice daily and half life is 3-4 hrs; thus it is necessary to be administered frequently in order to maintain the desired concentration. Therefore, Aceclofenac is an ideal candidate for sustained release formulation, resulting in more reproducible drug absorption and reducing the risk of local irritations.5

DRUG PROFILE (ACECLOFENAC)
Category: Anti inflammatory drug
Chemical name: 2-[2-[2-[(2,6-dichlorophenyl)amino]phenyl]acetyl]oxy acetic acid.
Chemical formula: C16H13C12NO4
Molecular weight: 354.18472 g/mol
Structure:

Indication:
Aceclofenac 100mg Tablets are indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.
Dose:
Adults
The recommended dose is 200 mg daily, taken as two separate 100 mg doses, one tablet in the morning and one in the evening.
Children
There are no clinical data on the use of Aceclofenac in children and therefore it is not recommended for use in children.
Elderly
The pharmacokinetics of Aceclofenac are not altered in elderly patients, therefore it is not considered necessary to modify the dose or dose frequency.
Toxicology:
No new preclinical data have been submitted and none are required for this application.
Pharmacokinetics:
After oral administration, aceclofenac is rapidly and completely absorbed as unchanged drug. Peak plasma concentrations are reached approximately 1.25 to 3.00 hours following ingestion. Aceclofenac penetrates into the synovial fluid, where the concentrations reach approximately 57% of...

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EUDRAGIT S100
Eudragit S100 are anionic copolymers based on methacrylic acic and methyl methacrylate.
Chemical structure:

Chemical name: : Poly(methacylic acid-co-methyl methacrylate) Molecular weight: approx. 125,000 g/mol

Category: Coating material
Targeted Drug Release Area: Colon delivery
Dissolution: pH 7.0
Characteristics:
• Granulation of drug substances in powder form for controlled release.
• Effective and stable enteric coatings with a fast dissolution in the upper Bowel.
• Site specific drug delivery in intestine by combination with EUDRAGIT® S grades.
• Variable release profiles.
Acid Value: 190 mg KOH/ g polymer
Glass Transition Temperature (Tg): >150°C

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