NAPROXEN & ESOMEPRAZOLE

Farzana Sultana BPH 04806682Razia Sultana Riza BPH 04806709Tahmina BPH 04806703Sumona Alam BPH 04806689Rozi Hasan BPH 04806767Nazmus Sakib BPH 04806686

Naproxen & esomeprazole Modified-release tablet containing enteric-coated (gastro-

resistant) naproxen and film-coated esomeprazole. Oval, yellow tablet marked '500/20' or ‘375/20' in black

ink.

Naproxen & esomeprazole

Composition

Composition

JustificationJustification of use Ingredients

API Naproxen & Esomeprazole

Polymer Hypromelloses, Ethylcelluloses, Opadry Clear, HPMC K15M Premium CR

Plasticizer Tryethyl Citrate, Opadry Clear

Disintegrant Croscarmellose sodium

Binder Povidone (PVP K90), Povidone (PVP K30)

Filler Lactose monohydrate

Solvent lsopropyl alcohol, Methylene chloride, Methanol, Water

Lubricant Macrogol PEG 400, Magnesium stearate

Antiadherent Magnesium stearate

Surfactant Poloxamer 188 (Lutrol P68)

Colorant Opadry Brown 02B86964

Printing Ink Hypromellose,Iron oxide black (E172), Propylene glycol.

Manufacturing Process1.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).

Manufacturing Process6. 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.

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.

DosageThe 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.

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 

Naproxen & esomeprazoleBrand Name : DEMOVO 375 DEMOVO 500 VIMOVO DINOVO 375/20 DINOVO 500/20