SK 713™: Unique Delivery Technology

for Nutraceutical, Cosmeceutical, and Pharmaceutical Preparations

What Is It?

• SK 713™ is a unique, proprietary delivery technology composed of delivery spheres shown to enhance active ingredient uptake and bio-availability
• Produced using a highly specific process not only helps amplify the absorption and while-the ability of enveloped ingredients, but also provides direct benefit to physiology
• Technology can be augmented to match desired outcome of formula
• May be applied to targeted portions of formula, or total compound
• Direct benefits of SK 713™ also pass on to cells, or the actual target of the delivery technology
• SK 713™ is very stable and possesses extensive shelf life
• Ingredients treated with SK 713™ acquire better stability as well
• Capable of use in both ingestible and topical preparations
• Effective with both water and fat soluble compounds, simultaneously
• Able to envelope multiple nutrients within each transport sphere creating maximum synergy
• Benefits provided are both direct and indirect. SK 713™ enhances nutrient uptake and also delivers a direct cholinergic and homeostatic benefit to cellular physiology

Absorption

“Whatever the nutritional potential of a food, its contribution is nonexistent if it does not pass the test of absorption. Those nutrients that have not been transferred through the intestinal mucosal cell to enter the circulation have, for all nutritional intent and purpose, have never been eaten. The variety of nutrients from the organism’s environment that have been made available by absorption must be transported through the circulatory system to the aqueous microenvironment of the cells. There, they serve their ultimate purpose: participation in the metabolic activities in the cells on which the life of the total organism depends.”

—Ruth L. Pike and Myrtle L. Brown, Nutrition: An Integrated Approach, John Wiley & Sons, 1984 , p. 283

SK 713™ is customizable depending on desired effect of specific formulation

• SK 713™ is customizable depending on desired effect of specific formulation
• Technology can be augmented to match desired outcome of formula
• May be applied to targeted portions of formula, or total compound
• May be used on virtually any formula of an aqueous nature
• May also be applied as a coating to powders, or added in dry form to other powders for reconstituting with liquids.
• Coating of SK 713™ acts to increase solubility and uptake of dry powders
• Direct benefits of SK 713™ also pass on to cells from dry powders (this technology is not available through any other known source)
• SK 713™ is very stable and possesses extensive shelf life
• Ingredients treated with SK 713™ acquire better stability as well

Surface Tension of SK 713™ Sphere vs. standard liposomal sphere

• In independent clinical testing, both an SK 713™ Sphere and a standard liposomal sphere were measured for contact angle reflection of light, with the drop of compound on glass, a non-reactive surface. A higher contact angle signifies a higher surface tension.
• The standard liposomal sphere demonstrated a contact angle of 39, while the SK 713™ Sphere contact angle was measure at 47.7.
• The SK 713™ Sphere was shown to have a 22.3% greater degree of contact angle, thereby demonstrating a significantly greater degree of surface tension, all due to the unique production methods of SK 713™.

SK 713™ Advantages for Ingestion

• SK 713™ spheres, at a small micron size, create absorption sublingually for a quick lift of nutritional energy.
• The transport spheres help protect many of the delicate nutrients from the harsh environment of the stomach. This allows more nutrients to reach to small intestine where absorption occurs.
• SK 713™ spheres help increase surface area of nutritional concentrate helping it to cover a larger area of the small intestine wall where absorption takes place. More surface area means more opportunity for comprehensive absorption.
• Spheres are able to hold both fat and water soluble nutrients which greatly enhances overall synergy. Typically, other transport spheres created in the body hold either fat or water soluble nutrients, not both.
• There is a great increase in smaller particle size uniformity as the vitamins, minerals and hundreds of compounds in the botanicals travel into the bloodstream simultaneously within the spheres. This creates tremendous synergy.

SK 713™ Advantages for Topical Use

• SK 713™ spheres envelope a multitude of active and synergistic compounds allowing them to be delivered simultaneously upon application. This helps to ensure the greatest efficacy.
• SK 713™ can be used with peptides, amino acids, botanicals, vitamins, minerals, etc., and may be with any or all actives in the combination and effect desired.
• The SK 713™ spheres create a sustained release effect thereby allowing active materials to more thoroughly penetrate and act for longer periods of time. This also helps to ensure optimum benefits.
• The unique aspect of SK 713™ technology helps to create an electrostatic repulsion. This effect dramatically improves the absorption and utilization of active compounds at the epidermal and dermal layers because the repulsion effect is akin to creating a direct non-occlusive action. Non-occlusive application is the key to create a transepidermal osmotic gradient, which is believed to be the driving force for the transport of vesicles into the skin (Cevc and Blume, 1992).
• The unique and proprietary processing of SK 713™ allows the ionic minerals to be stabilized within the phospholipid matrix while also creating a sustained release of ions in unison with release of active compounds.

Clinical Research with SK 713™ Enhanced Multi-Nutrient Supplement

• Using Phase Contrast Microscopy to examine live blood cells, our group evaluated whether an SK713 SLP encapsulated liquid multinutrient complex could enhance morphological, hematological and rheological changes in the blood after supplementation, indicative of enhanced speed of absorption, bioavailability, and utilization of nutraceutical ingredients.
• Subjects then consumed either one ounce of bottled water (control) or one ounce of the VMP35 liquid multinutrient (active). At 5 minutes from intake, a second blood sample was taken and differences from the first sample were evaluated. Subjects in the control group (post-control) then consumed one ounce of the VMP35 multinutrient complex (MNC) and had a third blood sample drawn 5 minutes after intake. Results: No changes were observed between the before and after samples in the water control. Significant differences were observed between the before and after samples in the active group, the post-control active group as well and the 30 minute post-active groups. Conclusion: The SK713 SLP technology effectively delivered nutrients into the blood in less than 5 minutes from intake and exerted a sustainable effect for at least 30 minutes post intake sufficient to cause significant improvement in morphological, hematological and rheological properties.

Case Report on Topical Application Using SK 713™

A male volunteer had blood drawn in preparation to create a single 4 cc dose of platelet rich plasma (PRP). The PRP was produced using the Selphyl® system. The 4 cc’s were divided in half with 2 cc’s each added to Selphyl® provided test tubes with Calcium Chloride. Each tube was mixed according to directions, and then an appropriate amount of SK 713™ was added to one of the tubes. Next, the untreated Selphyl® mixture was swabbed onto the left inner forearm, while the Selphyl®/SK 713™ mixture was swabbed onto the same area of the right arm.

Within 5 minutes, the liquid mixture of Selphyl®/SK 713™ had completely absorbed into the right arm. However the straight Selphyl® liquid on the left arm was still wet and with some areas of tackiness, and forearm hair was matted. This demonstrated a significant difference in absorption. In addition, within 1 hour, there was a demonstrable difference in physiological effect as well. The following slides show the arm treated with the Selphyl®/SK 713™ mixture had transdermal absorption with concurrent vasodilation, as compared to the left arm treated with the straight Selphyl® mixture that showed no visible effect whatsoever.

Clinical Results on Dermal Permeation with SK 713™ added to PRFM

At the 4 hour mark, platelets had successfully passed through the SC. At the 24 hour mark platelets had reached the basal cell membrane.

In addition, there was a 4 fold increase of fibrin at the basal cell membrane at hour 24.

Also at hour 24, there was a significant increase in interleukin-6, a pro-inflammatory cytokine. This demonstrated that the PRFM that had reached the basal cell membrane was active.

No morphological changes in skin tissue were observed meaning there was no tissue damage, and the PRFM did in fact pass through intact skin tissue.

Clinical Results on Dermal Permeation with SK 713™ added to 1% Lidocaine HCL

• 1% Lidocaine HCl mixed with SK 713™ was applied to skin tissue at a level of 405 mcg.
• Analysis revealed a four fold increase in permeation at 24 hr. compared to the 2 and 4 hr. exposure time points, even though typical lidocaine has very poor ability to pass intact skin.
• Measurements taken at hour 24 demonstrated a level of lidocaine at just over 300 mcg at the basal cell membrane.
• Topical lidocaine, even with occlusive dressing in place for 24 hours, has shown a permeation of roughly 16%.
• In contrast, the lidocaine mixed with SK 713™ with a single application and no dressing, at the 24 hour mark, showed a permeation level of 75%.

Topical Anesthetic Human Case Study

Prep for In-office neurotoxin injection David A. Silberman, M.D., F.A.C.S.

• In a medical office, 25 patients underwent injection therapy for wrinkles utilizing a neurotoxin. All patients had this placed into the glabellar area.
• Placement of 2 cc injectable 1% lidocaine was removed from the syringe and placed into the 2 ounce cup. Placement of 2 cc injectable 1% lidocaine was removed from the syringe and placed into a second 2 ounce cup. Approximately 2 mL of SK 713™ was added to this 1% lidocaine and mixed well for 30 seconds.
• The lidocaine and SK 713™ was applied on the left side glabellar region and lidocaine 1%neat (no technology) was placed on the right side.
• After three minutes time, the neurotoxin was then injected using a 31 gauge needle into the glabella region on both right and left sides.
• The site where lidocaine with SK 713™ was applied showed a marked decrease in the discomfort from the injection of the neurotoxin. On this side, no patients registered higher than a three on the pain scale from 0 to 10. All patients noted a pain level of five and above on the injection side where lidocaine only was applied.

Conclusions

• Lidocaine 1% injectable is known to have no effect when placed topically. It is only effective when placed through the epidermis via a syringe.
• However, a mixture of 1% lidocaine with SK 713™ showed a rapid onset of action (3 minutes) even though it was applied topically.
• The duration of de-sensitization for the topical 1% lidocaine/SK 713™ mixture was approximately 90 minutes in all patients. This is equivalent to the de-sensitization that occurs with 1% injectable lidocaine.
• Several patients were re-tested using a standard pin-prick device at the 5 and 10 minute mark post application of topical 1% lidocaine/SK 713™. In all cases the de-sensitization had increased as compared to the 3 minute mark.

Evaluation of Topical Formulations for Dermal Permeation

Including retention of activity for topical antibiotic (clindamycin)

• Studies were conducted to determine the permeation and retention of activity of an antibiotic in a trans-dermal model, using the drug as a control vs. the drug combined with SK 713™.
• Untreated tissue and the SK 713™ material neat applied to the skin tissue model were also used as controls.
• Readings were taken at 1, 4, and 24 hours comparing all samples.

Summary of Clindamycin topical applications

• In the receiver solution below the skin tissue model, The concentration of clindamycin, was high in tissues dosed with clindaymcin alone. Low concentrations of clindamycin were observed in tissues dosed with clindamycin combined with SK 713™.
• Measurable concentrations of clindamycin were observed in tissues dosed with Clindamycin/SK 713™ whereas no measurable concentrations (BLQ) were observed in any other treatment group including tissues dosed with Clindamycin alone.
• Only the clindamycin/SK 713™ material showed retention in the skin tissue itself, and this amount was measureable.
• The concentration of clindamycin was high in donor samples collected from tissues dosed with clindamycin alone. Medium concentrations of clindaymcin were observed in tissues dosed with clindamycin/SK 713™, demonstrating improved permeation.
• Based on the donor samples, it appears the Clindamycin/SK 713™ material was taken into the skin tissue faster and more efficiently than the control drug. Moreover, there was a significantly higher level of the active test article within the tissue as compared to control when measured at 24 hours. This is extremely important since increased retention of antibiotic (transdermally) can mean less need for antibiotic and potentially less antibiotic resistance, more cost efficiency, and a much better compliance by the patient with far fewer side effects.

A biological price of antibiotic resistance

Major changes in the peptidoglycan structure of penicillin-resistant pneumococci. Proc Natl Acad Sci U S A. 1990 Jul;87(14):5415-9.

• Composed of a material called peptidoglycan, the bacterial cell wall is essentially a tremendously long polysaccharide which wraps around the bacterial cell membrane. The parallel strands of polysaccharide are cross linked by short peptides to provide additional structural strength.
• Pneumococcal strains with greatly elevated levels of resistance to penicillin have by now been described with increasing frequency worldwide. The mechanism of antibiotic resistance in these strains involves the molecular remodeling of cell wall.
• Major peptide species (70% or more) of resistant cell walls were abnormal branched-stem peptides carrying Ala-Ser or Ala-Ala dipeptides.
• The outermost layer of the skin, the stratum corneum (SC), is comprised of primarily keratin devoid of water along with lipids to help repel water as well.
• Therefore, since the SK 713™ technology can open the SC allowing large molecules to pass through, it can, in theory, also open/relax the peptidoglycan bacterial cell wall allowing the antibiotic access to disrupt the bacterial physiology more efficiently and thoroughly.

Example of Application in Field

“The tech product was very amicable to work with as a base component mixture. It was easily homogenized with active pharmaceutical ingredients (API’s) and post 24h,48h, 7d it held target viscosity completely. Final preps passed all evaluations of tactility, color, smell and residue. We unofficially tested for absorption and noticed a rapid rate in this area compared to some of our other base enhanced products. There was no sticky residue remaining which is a common complication for absorption enhancement bases. I was pleased with the final product for these reasons stated.

“I look forward to exploring the possibility of exploring the infinite possibilities that this product may create and hope to offer my assistance in any way.”

— Amy, Compounding Pharmacy Technician

Testing & Result Using Technology with Human Platelet Lysate to Improve Absorption

Email from Doctor

“Dear Steve

“Our testing with the glide serum with you liposomes has gone very well and we would like to purchase more of your product. Your product is amazing and we do want to advance it.

“Dr. T”

SK 713™ Summary

• Unique and proprietary delivery system to enhance nutrient uptake
• All-natural, utilizing GRAS ingredients
• Customizable for both liquid and dry formulations
• Cannot be reverse-engineered
• Does not require special equipment in manufacturing and may be utilized on-site at most manufacturing facilities
• Creates better product efficacy and product “exclusivity”
• Has demonstrated incredible ability to effect healing using topical/transdermal applications.