Other Products & Pipeline Therapeutics

Anti-Aging Cell Repair Cream - Enhanced Skin Penetration and Dermal Bioavailability of Micronutrients 

The CellMedics^® Anti-Aging Cell Repair Cream is a patented formulation that contains the highest concentration of stable micronized L-ascorbic acid (30%). L-ascorbic acid (LAA) is the chemically active form of vitamin C. LAA protects the skin from oxidative stress by neutralizing free radicals and provides photoprotection thereby limiting chronic UV damage. LAA stimulates new collagen production in addition to improving the quality of the collagen molecule itself. Clinical studies have shown that the topical use of LAA increases collagen production in human skin. The CellMedics Anti-Aging Cell Repair Cream is powered by patented Bioavailant^® Deep Tissue Delivery Technology. It enables greater stability of LAA and significantly increases dermal absorption of hydropholic micronutrients. It is non-irritating to the skin and can be used even under the delicate eye area & on the neck.

Ingredients

1. 30% L-Ascorbic Acid (Vitamin C). The highest concentration of stable micronized L-ascorbic acid available in any topical formulation. L-ascorbic acid's beneficial effects on human skin physiology are dose dependent.
2. 1% Hyalauronic Acid (HA). HA is a powerful humectant, binding up to 1,000 times its weight in water. HA promotes cell proliferation, wound healing, reduces scarring and facilitates healing of venous leg ulcers.
3. 1% N-Acetylcarnosine. Carnosine rejuvenates aging skin cells by slowing telomere shortening and inhibiting protein glycation, thereby reducing cross-linking and preserving elasticity.
4. 2% Salicylic Acid (BHA). Beta hydroxy acid (BHA) is an exfoliant that accelerates skin cell turnover and helps clear pores. It is soluble in oil and can exfoliate oily skin. It has a beneficial effect on acne, pigmented lesions, and sun damaged skin.

Developmental Transdermal and Transungual Formulations

Ibuprofen Arthritis & Pain Cream - Patented

Key ingredient: Ibuprofen (IBU)

In an anti-inflammation comparative study using the carrageenan-induced rat paw edema model, statistical analysis showed that a patented 5% ibuprofen anhydrous cream (CellMedics^®) was over twice as effective at inhibiting inflammation associated with arthritis and pain at 1h, 2h, 3h and 4h time points compared to a 5% ibuprofen o/w cream, a 5% ibuprofen pluronic lecithin organogel and a placebo cream. Notably, the CellMedics^® 5% ibuprofen cream group did not experience a decline in % inhibition at 4 hours as did the other 5% ibuprofen formulations. This suggests that both the degree and duration of inflammation inhibition were related to the properties of the topical formulations used to deliver ibuprofen.

In an open, single-center, nonrandomized pharmacokinetic study, the relative bioavailability of ibuprofen in plasma, subcutaneous adipose and skeletal muscle tissue was evaluated in human subjects after topical administration of ibuprofen 200 mg in a patented cream formulation (CellMedics^®) and after oral dosing with 200 mg ibuprofen (Advil^®). In vivo microdialysis in subcutaneous and muscle tissues was performed and plasma samples were taken simultaneously immediately after the final doses from both treatments. Ibuprofen tissue/systemic circulation bioavailability ratios were calculated and then compared by one-sample t-tests. The relative bioavailability of ibuprofen in subcutaneous adipose and skeletal muscle tissue was substantially higher after topical compared with oral dosing whereas relative plasma bioavailability was manyfold lower. This study suggests that because of favorable percutaneous penetration characteristics and low systemic bioavailability, topical administration of CellMedics^® Ibuprofen Cream offers the advantage of local, enhanced drug delivery to affected tissues while reducing the potential for systemic adverse effects compared to oral ibuprofen dosing.

Aspirin Cream - Patented

Key ingredient: Aspirin (acetylsalicylic acid)

Aspirin is not stable in aqueous formulations or in any of the common solvents used in topical pharmaceuticals such as glycols or lower aliphatic alcohols and therefore will degrade by hydrolysis, glycolysis and trans-esterification all of which will be promoted by any pH higher than about 3.5. Thus, its shelf life in such solvents is far too short to permit the development of a stable topical aspirin formulation. A topical aspirin formulation (CellMedics^®) that does not contain water, glycols or lower aliphatic alcohols was tested for stability. Stability testing was done using a selective and sensitive high performance liquid chromatographic (HPLC) method for the simultaneous determination of aspirin and its main decomposition product Free Salicylic Acid (FSA). In this stability test, the amount of aspirin in the topical formulation following 6 months of storage at room temperature of 23°C±3°C and relative humidity of 35%±5% was found to be greater than 99% of the labeled amount. There was no significant aspirin deterioration.

Terbinafine Cream for Nail Fungus - Patented

Key Ingredient: Terbinafine Hcl

Three formulations were tested for their efficacy against the organism T. rubrum and permeation across human cadaver nails using an infected nail model. Data was recorded in accordance with SOP 1011 and 1009, checked as described in SOP 1007 and presented as the average percentage of Luminescence units (representative of ATP released from viable organisms) for each Test and Reference item mean ± standard deviation compared to the infected control for the experiment. ATP was used as a biomarker to determine efficacy of the Test and Reference items where ATP levels equivalent to the infected control indicated low efficacy and levels equivalent to the non-infected control indicated high efficacy. The data was statistically analyzed using the Tukey’s HSD test to determine differences between formulation groups. The CellMedics^® 1% terbinafine cream demonstrated the highest efficacy of the topical formulations tested; applied once daily for 14 days it was found to be statistically similar to the non-infected non-treated control (e.g. representing total kill).

Methotrexate Cream for Warts - Patented

Key Ingredient: Methotrexate

In an open-label non-randomized clinical investigation, a CellMedics^® 0.5% w/w methotrexate cream was compared to a 5-fluoruracil-salicylic acid solution in the treatment of warts on the hands and feet. Visual assessment was done at 4 and 8 week time points by a dermatologist specializing in the treatment of warts. Twice daily application of the CellMedics^® 0.5% methotrexate cream was judged to be significantly more effective (85% resolution) than twice daily application of the 5-Fu-salicylic acid solution (62% resolution). Toleration for the methotrexate preparation was high. The methotrexate cream was judged to be less irritative than the 5-Fu-salicylic acid solution.

Pipeline Formulations, Indications and Targets