Name of the medicinal product: Dolgit® Active substance (INN): ibuprofen Pharmaceutical form: gel for external use
Composition:
100 g of gel contains: active substance: ibuprofen 5 g; excipients: isopropanol, dimethylhydroxymethyldioxolane (Solketal), poloxamer 407, medium chain
triglycerides, purified water, lavender oil, orange blossom oil (nerol oil). Description: transparent gel, colorless to slightly opaque, with a characteristic odor. Pharmacotherapeutic group: Non-steroidal antirheumatic agent, propionic acid derivate.
Pharmacological properties
Ibuprofen is a non-steroidal antiphlogistic/analgesic agent proved to be effective via the inhibition of the
prostaglandin synthesis in the usual animal experimental inflammation models. In humans, ibuprofen reduces
aches, swelling and fever caused by inflammation.
Furthermore, ibuprofen reversibly inhibits the ADP and the collagen induced platelet aggregation.
Pharmacokinetic properties
Following oral application, ibuprofen is partly resorbed already in the stomach and finally completely in the small
intestine. After hepatic metabolisation (hydroxylation, carboxylation) the pharmacologically inactive metabolites
are eliminated completely mainly renal (90 %) but also biliary. The elimination half-time is 1.8– 3.5 hours in
healthy persons, hepatopaths and renal patients; the plasma protein binding is about 99 %.
Following cutaneous application ibuprofen is possibly taken up into a dermal depot and from there emitted slowly
into the central compartment. The percutaneous resorption rate (bioavailability) of ibuprofen, determined by
comparative examinations (oral, topical application), is approx. 5 %.
The observed therapeutic efficacy is explained primarily by the therapeutically relevant tissue concentrations of
the drug beneath the area of the application. The penetration to the site of action may vary depending in the extent
and kind of affection as well as the area of application and site of action.