DIKLOFENAC DIETILAMIN

• Contoh sediaan : Voltaren® Emulgel

• 1 g Voltaren® Emulgel mengandung :

• 11,6 mg zat aktif diklofenak dietilamin

yg setara dengan

• 10 mg natrium diklofenak

• There may be pain and, occasionally, tissue damage at the site of injection when diclofenac is given intramuscularly.

• Diclofenac suppositories can cause local irritation.Transient burning and stinging may occur with diclofenac ophthalmic solution;

• the topical treatment of pain, such as in osteoarthritis.

BAHAN DASAR

• Emulsi minyak dalam jelly aqua.

BAHAN PENGENTAL• POLIMER ASAM AKLIRIK

Because of..

• High molecular weights water soluble homopolymer of acrylamide are

reported to possess very high viscosity in low concentration, transparency,

film forming properties and areuseful in formation of gel.

• The diclofenac sodium gels were prepared by using different concentration

of polyacrylamide for topical drug delivery with an objective to increase

transparency and spreadability.

• Spreadability and consistency of polyacrylamide gel containing diclofenac

sodium (F9) were 6.5g.cm/sec and 5mm as compared to 5.5g.cm/sec and

10mm respectively of marketed gel, indicating good spreadability and

consistency of the prepared gel

Procedure of gel preparation:

• About 3g of diclofenac sodium was weighed and dissolved in 5g of isopropyl alcohol, to this solution, specified quantity of glycerin or propylene glycol or cocodiethanolamide was added and dissolved (solution A).

• Weighed quantity of polyacrylamide was added to the 75g of distilled water containing 0.1g of sodium metabisulfide as antioxidant and stirred to dissolve the same (solution B). Solution A and B were mixed thoroughly and the final weight was made upto 100g.

polyacrylamide

• an anionic surfactant employed in a wide

range of nonparenteral pharmaceutical formulations and cosmetics

• detergent and wetting agent effective in both alkaline and acidic conditions.

ISOPROPYL ALKOHOL

• Isopropyl alcohol (propan-2-ol) is used in cosmetics and pharmaceutical formulations, primarily as a solvent in topical formulations.

• Disinfectant; solvent.

ANTI OKSIDAN

• NATRIUM METABISULFIT

• Sodium metabisulfite is used as an antioxidant in oral, parenteral,and topical pharmaceutical formulations, at concentrations of 0.01–1.0% w/v, and at a concentration of approximately 27% w/v in intramuscular injection preparations.

PROPILEN GLIKOL

• Antimicrobial preservative; • disinfectant;• humectant; • plasticizer;• solvent; • stabilizing agent;• water-miscible cosolvent

Because of..

• generally regarded as a relatively nontoxic material

• In topical preparations, propylene glycol is regarded as minimally irritant

But not more than

• propylene glycol at up to 25 mg/kg body-weight.

• Formulations containing 35% propylene glycol can cause hemolysis in humans.

LIQUID PARAFFIN

• Emollient;

• lubricant;

• oleaginous vehicle;

• solvent;

• vaccine adjuvant