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PRESENTATION
FUNGISOME® Gel is a pale yellow semisolid Liposomal gel, for topical use, available in pack size of 5g.
COMPOSITION
Each gram of FUNGISOME® Gel contains 1mg of Amphotericin B I.P., in hydrocolloid-based liposomal gel.
DESCRIPTION
Amphotericin B is a macrolide polyene antibiotic produced by strain of soil bacteria Streptomyces nodosus.

One side - 7 hydroxyl groups - Hydrophilic
Other side - 7 Double bonds - Lipophilic

Amphipathic Molecule
Molecular Formula - C47 H73 NO17
Molecular Weight - 924.09

It is odourless and tasteless powder, insoluble in water and alcohol. It has to be stored in an airtight container. Amphotericin B being cytolytic is most effective drug both for the treatment of Mycosis as well as protozoan infections viz. Leishmaniasis. The resistance to Amphotericin B, unlike azoles, is very rare. Amphotericin B has higher affinity for ergosterol than for cholesterol. High affinity of Amphotericin B for ergosterol results in its binding predominantly to fungal, leishmania or naegleria cells as they contain ergosterol or resembling compounds. Resulting ergosterol – Amphotericin B complex increases membrane permeability of fungal / pathogen cells leading to cell lysis. Toxicity is caused by Amphotericin B binding to the membrane cholesterol present in human cells / tissues. Thus its therapeutic effect and toxicity have the same mechanism.
SKIN FUNGAL INFECTION
Dermatophytosis or fungal infections of skin “ringworm or tinea” are the common infections of the skin caused by dermatophytes. These fungi live as the parasite on keratinised tissues like hair, nails and skin. They have enzyme keratinase and thus penetrate and infect these tissues. The dermatophytes are classified, according to the characteristics of macroconidium into three genera- Microsporum, Trichophyton and Epidermophyton. Each genera is further divided into different species.

The group of opportunistic fungi causing superficial cutaneous, mucosal or nail infections is Candida. The oral, vaginal, cutaneous or nail candidosis is mostly caused by Candida albicans. Chronic mucocutaneous candidosis is seen in patients with impaired immunity due to T lymphocyte activation defect.

The other superficial fungal infections are Pityriasis versicolar. These are common recurrent infections of the stratum corneum caused by Malassezia furfur. It can cause hypo- or hyper-pigmented patches. There are some not so common fungal lesions like white and black Piedra, Tinea nigra and Scytalidium infections etc. Due to high incidence of HIV, modern modalities of treatment in surgery and medicine like organ transplants, cancer-chemotherapy, radiotherapy, parenteral nutrition, broad spectrum antibiotics etc., there is remarkable change in the pattern of fungal infections.
PROBLEMS WITH TOPICAL AMPHOTERICIN B
Its use as topical application was restricted as it is not absorbed through mucosa or skin as such. It is highly lipophilic and hydrophobic in nature and can not be dissolved in water. Thus a liposomal Gel formulation has been developed.

After encapsulation in liposomes percutaneous absorption of Amphotericin B is markedly enhanced and very little drug goes into systemic circulation1.The nano-liposomes along with the drug are able to cross the biological barrier of the skin to get lodged in dermis and epidermis. These lipid formulations of Amphotericin B are very effective and thus require very low drug concentration.
LIPOSOMES IN DERMATOLOGY
Liposomes are concentric bilayer multi-compartmental, water-filled lipoidal vesicular carriers composed of phospholipids. They are versatile drug delivery carriers and are used as super solvent systems. Using nano-liposomes of Amphotericin B, transdermal delivery is made possible.

Enhanced drug penetration across the tough and dense lamellar lipidic matrix of stratum corneum is achieved as a result of favorable hydro-lipophylic micro-environment built in by these micro carrier systems, consisting of phospholipids in highly hydrated form.
Drug encapsulation into nanosomes enables:
  • Enhance drug transport across skin.
  • Get super saturation effect of the drug i.e. greater concentration and residence time in the epidermis and dermis.
  • The action of the drug is prolonged and pronounced.
  • The drug is needed in lesser concentration to bring about the desired effect thus its safety is improved.
Unique water holding capacity of Phospholipids provide with:
  • Super hydration effect.
  • Skin lipid enrichment.
  • Moisturizing, emollient and skin nourishing.
Encapsulation of Amphotericin B in uniquely and specifically designed liposomes constituted of strategic mix of lipids, has resulted in Fungisome® Gel-a nanosomal Amphoterisome B gel-the most effective treatment for superficial fungal infections.
LIPOSOMAL AMPHOTERICIN B GEL FUNGISOME® Gel
Liposomes designed to intercalate Amphotericin B are stabilized as nanosomes in Gel formulation (non-irritating and least allergic reactions) which is a very effective vehicle for topical application.
PHARMACOKINETICS / PHARMACODYNAMICS
The nano-liposomes along with Amphotericin B are able to cross the biological barrier of the skin to get lodged in dermis and epidermis. The Lipids being the natural constituents of the skin are highly compatible and non-toxic. The nano-liposomal preparation of Amphotericin B, is non-irritating to the skin and do not usually cause allergy. No other topical Amphotericin B preparation is available in the market.

Amphotericin B has higher affinity for ergosterol than for cholesterol. Fungal, leishmanial or naegleria cells contain ergosterol or resembling compounds. Resulting ergosterol – Amphotericin B complex increases membrane permeability of fungal / pathogen cells leading to their lysis.
ADVANTAGES OF FUNGISOME® Gel
  • Topical use of Amphotericin B made possible
  • Most effective topical Antifungal all fungi including dermaophytes
  • Prolonged and pronounced drug action
  • Effective at low doses
  • Moisturizing, emollient and skin nourishing gel
  • Non-allergic and non-immunogenic
  • Stable preparation
INDICATIONS
  • Chronic and recurrent fungal infections including Dermatophytes
  • Dressing after wound debridement
  • Burn wound dressing
  • Bed sores
  • Around the tubes going inside body
  • Sinuses
  • Vaginal candidiasis
  • Diaper rashes
  • Cutaneous leishmanial ulcers
SAFETY
FUNGISOME® Gel is very safe to use on skin even in children
ADVERSE DRUG REACTION & SAFETY PROFILE
Adverse effects of FUNGISOME® Gel have not been reported.
USAGE
Apply FUNGISOME® Gel to the affected part gently and preferably after bath once daily.
DRUG INTERACTIONS
FUNGISOME® Gel can be used as part of combination with topical or systemic therapy but one should remember that two topical preparations should not be used concomitantly.
CONTRAINDICATIONS
FUNGISOME® Gel is contraindicated in patients who have developed serious hypersensitivity reaction during previous application or are hypersensitive to any of the constituents of the product.
SPECIAL PRECAUTIONS TO BE TAKEN
During pregnancy and lactation there are no reports of any adverse effects. Topically it is a very safe drug.
STORAGE
Keep out of reach of children
Store below 25oC and away from heat
Do not freeze
Keep tube tightly closed after use
References
  1. Michael Mazei and Vijeyalakshmi Gulasekharam, , Life Science,1980; Vol. 26: 1473-1477.
 
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