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For the use only of a Registered Medical Practitioner of a Hospital or a Laboratory
PRESENTATION
PSORISOME Gel is a pale-yellow semisolid liposomal gel, containing Dithranol I.P. microencapsulated in vesicular form.
COMPOSITION
Each gm of PSORISOME Gel contains 5mg of Dithranol I.P (synonym: Anthralin), in hydrocolloid-based liposomal gel and 150 mg of total lipids (lecithin and cholesterol in 1:1 molar ratio)..
DESCRIPTION
Liposomes are microscopic vesicles composed of one or more lipid bilayers arranged in a concentric fashion enclosing a number of aqueous compartments. These supra-microstructures represent water-filled pouches enclosed by lipoidal membranes.

Empirical formula C14H10O3
Molecular weight 226.23
CAS registry number is 1143-38-0
Dithranol is the drug of choice for the tropical treatment of chronic plaque psoriasis and many other skin afflictions such as Chronic Eczema, Dermatophytoses, Alopecia areata and Seborrheic dermatitis, etc.

Dithranol (a synthetic version of historical GOA POWDER) belongs to the family of hydroxyanthrones and has been used in the treatment of psoriasis for more than a century. Unlike corticosteroids, Dithranol has prolonged remission period and is devoid of any systemic toxicity. The unmatched therapeutic efficacy of Dithranol stems from its ability to generate free radicals, which attack in ubiquity on multiple molecular targets. Dithranol has been shown to accumulate in mitochondria, where it induces morphological and functional changes. This affects the cellular energy supply which, in turn, results in inhibition of energy dependent process such as DNA replication that slows down excessive cell division as seen in psoriasis plaque.

The psoriatic hyperproliferative epidermis contains the elevated levels of cyclic guanosine monophosphate (cGMP). Dithranol has been shown to reduce the elevated level of cGMP back to normal and this could represent an additional mechanism of action.

Dithranol is initially oxidized to anthronyl radical, which on subsequent oxidation, leads to formation of Danthron (1,8-dihydroxyanthraquinone), and Dianthrone (1,8,1',8-tetrahydroxyl dianthrone; dithranol dimmer) and finally to insoluble oxidation products. Exposure to sunlight accelerates the breakdown of Dithranol to Danthron.

In PSORISOME Gel liposomal Dithranol, the degradation of the drug is strategically designed to be so controlled that it generates the desired free radical, anthronyl with anti-psoriatic activity. Encapsulation in liposomes minimizes irritation and staining otherwise caused by Dithranol as the production of causative oxidation products Dianthrone and Danthron are restrained in liposomal preparation.

MAJOR PROBLEMS WITH CONVENTIONAL DITHRANOL
Dithranol is not patient-friendly because of:
  • Severe skin irritation, stinging, burning and dryness of skin
  • Staining of skin and clothes
  • Perilesional erythema and inflammation
  • Folliculitis and contact allergy
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
INDICATIONS
PSORISOME Gel should be used in adults and children above 12 years. PSORISOMEGel 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.
COMBINATION THERAPY
PSORISOMEGel 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.
CONTRAINDICATIONS
PSORISOMEGel is not recommended for use on the face and in flexural folds. PSORISOMEGel is contraindicated in patients who had an allergic reaction or hypersensivity to Dithranol (Anthralin), or any of the ingredient/excipient of PSORISOMEGel e.g. lipidic constituents, and antioxidants (BHT, SMBS).

In very rare instances, susceptible individuals may experience irritation with PSORISOMEGel. In case of any signs of local adverse reactions, patients should consult their physician.

CHILDREN
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.
USAGE
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.
SAFETY
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 PSORISOMEGel 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.
WARNING
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.
STORAGE
  • Keep out of reach of children
  • Store below 25C and away from heat and direct sunlight
  • Do not freeze
  • Keep tube tightly closed after use
ACKNOWLEDGEMENTS
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
 
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