PHARMACODYNAMICS OF PSORISOME® Gel
PSORISOME® Gel is a novel liposomal formulation with an innovative and unique interior design which provides remarkably enhanced therapeutic efficacy with minimal side effects compared to conventional Dithranol products available commercially.
Liposomes are micro-range exquisitely structured closed membrane vesicles made up of phospholipids which improve the overall performance of the drug. The latter is the resultant of the improved drug-target interaction at the cellular, intercellular and intracellular levels. The over-reactivity of the drug is also moderated to control the formation of oxidation products.
MECHANISM OF ENHANCED DRUG TRANSPORT BY LIPOSOMAL FORMULATION
Enhanced drug penetration across the tough and dense lamellar lipidic matix of stratum corneum is achieved as a result of favorable hydro-lipophilic micro-environment built-in by these micro-carrier systems. This keeps Dithranol molecule in a super-solubilized state within its membrane folds, composed of bio-surfactants. The carrier-skin lipid interaction helps in the partitioning of the drug and consequently facilitates the drug transport. Interaction of phospholipids in a highly hydrated form extraordinarily helps modifying the toughness of the skin transport-barrier in a most bio-acceptable manner.
Additionally, the liposomes in the hydrocolloid gel form are rheologically programmed to keep the drug confined to the affected site only, thus preventing its unwanted interaction with the perilesional normal skin.
In the clinical studies, PSORISOME® Gel (Dithranol 0.5% w/w) was found to have comparable antipsoriatic efficacy to that of an available conventional product containing 1.15% w/w Dithranol, that too without salicylic acid and coal tar.
The adverse effects such as perilesional erythema, irritation, burning sensation, staining of skin and clothing are negligible with PSORISOME® Gel compared to the other marketed Dithranol products.
ADVANTAGES OF PSORISOME® Gel
- Efficacy enhancement (Dithranol concentration reduction over 50%)
- Safety improvement (non-irritant, non-staining)
- Improved stability of Dithranol
- Improved aesthetic formulation
- Free from salicylic acid and other skin irritating agents
PSORISOME® Gel should be used in adults and children above 12 years. PSORISOME®Gel is recommended for topical treatment of stable chronic plaque-type psoriasis with no evidence of flare up and having limited number of lesions (less than 20 lesions), either by short contact (applications upto 30 minutes) or by continuous contact therapy method (see usage).
Although Dithranol has been used for many other skin afflictions such as Chronic Eczema, Dermatophytoses, Alopecia areata, Seborrheic dermatitis, etc., however, the treating physician may use their discretion for treating these indications.
PSORISOME®Gel can be used as part of combination with topical or systemic therapy but it is to be remembered that the two topical preparations should not be used concomitantly. Either one preparation has to be used in the morning and the other in the evening or on different days.
PSORISOME®Gel is not recommended for use on the face and in flexural folds. PSORISOME®Gel is contraindicated in patients who had an allergic reaction or hypersensivity to Dithranol (Anthralin), or any of the ingredient/excipient of PSORISOME®Gel e.g. lipidic constituents, and antioxidants (BHT, SMBS).
In very rare instances, susceptible individuals may experience irritation with PSORISOME®Gel. In case of any signs of local adverse reactions, patients should consult their physician.
In children below 12 years, PSORISOME® Gel should be used only under the supervision of the prescribing physician.
PREGNANCY AND LACTATION
PSORISOME® Gel is to be used with caution. However, there are no reports of its adverse effects.
As short term contact therapy-
- After bath apply PSORISOME® Gel gently over the affected area.
- Hands should be thoroughly washed with soap and water after application of Gel.
- After thirty minutes PSORISOME® Gel should be removed by washing with plenty of luke warm water (when removing the gel it is important not to use hot water or soap, as these can damage the liposomal structure contained in PSORISOME® Gel. The period between PSORISOME® Gel application and washing can be gradually increased over days beginning with 30 minutes.
- After washing apply good quantity of moisturizer/cream over the lesions.
- Healing of the lesions is usually seen with in 3-5 weeks of application or even earlier.
Adverse effects of conventional Dithranol products include perilesional erythema, burning irritation, skin and cloth staining.
PSORISOME® Gel may cause minimal skin irritation, burning and skin/fabric staining.
The clinical studies have revealed that PSORISOME®Gel is almost free of adverse effects. The improved tolerability and efficacy of PSORISOME® Gel have been attributed to the facilitated transport of liposomal Dithranol through the psoriatic epidermis and the formation of local lipidic micro-reservoirs of the drug. The controlled and prolonged release of drug from these micro-reservoirs leads to moderation of chemical reactivity of Dithranol which eventually is responsible for lack of skin irritation, staining and other adverse effects.
PSORISOME® Gel is to be used as directed by the physician. It is for external use only. Avoid contact with eyes and inside the nose, mouth, and all mucous membranes, as this may cause irritation.
- Keep out of reach of children
- Store below 25°C and away from heat and direct sunlight
- Do not freeze
- Keep tube tightly closed after use
PSORISOME® Gel has been developed at UIPS, Punjab University, India.
Indian Patent Application No. 610/DEL/2005 dated 21.03.2005
International Patent Application No. PCT/IN06/00113 dated 21.03.2006