7. Manufacturing Process
1.Naproxen and croscarmellose sodium (first quantity)
are mixed and granulated with a solution of povidone
in water, in a fluid bed processor with top spray.
Granules are dried to a LOD less than 2% w/w.
2. Croscarmellose sodium (second quantity) is added
and blended for 5 minutes.
3. Magnesium stearate is added and blended for 5 minutes.
4. The mixture is compressed into tablets.
5. Ethyl cellulose, HPMC, and triethyl citrate are
dispersed in a mixture of isopropyl alcohol and
methylene chloride (1:1 volume ratio).
8. Manufacturing Process
6. The dispersion is coated onto tablets to
produce a 8-9% weight gain, after drying.
7. Subcoating ingredients are mixed to form
a suspension and coated onto the tablets, then
the tablets are dried.
8. Drug loading ingredients are mixed to
form a dispersion and coated onto subcoated tablets by pan coating,
then the tablets are dried.
9. Drug layered tablets are coated with a
mixture of the protective coating ingredients,
and dried.
9. Mode of action : This tablet has a sequential-delivery
tablet formulation combining an immediate release
esomeprazole magnesium layer and an enteric coated
delayed-release naproxen core. As a result, esomeprazole is
released in the stomach prior to the dissolution of naproxen
in the small intestine. The enteric coating prevents
naproxen release at pH levels below 5 providing protection
against possible local gastric toxicity of naproxen.
Dosage
The adult dosage is one tablet twice daily. The tablets
should be swallowed whole with water, and not split,
chewed or crushed.Unlike the administration directions for
most NSAIDs, it is recommended that this tablets are taken
at least 30 minutes before food.
10. Use : Osteoarthritis, rheumatoid arthritis and ankylosing spondylitis
Side Effects :
Indigestion ,impaired sense of taste
Inflammation of sinuses
Back pain, dizziness, cough,constipation
Burning or discomfort of stomach, gas, headache
Contraindications:
Hypersensitivity to the active substances or to any of the excipients
Severe hepatic impairment
Severe heart failure
Severe renal impairment
Active peptic ulceration
Gastrointestinal bleeding, cerebrovascular bleeding or other
bleeding disorders
