TM

®

  Introducing Hydroxysomes®

An Innovative Patented Dermal Delivery Platform

exceeding metrics of other dermal delivery technologies

 

 

TECHNOLOGYHydroxysomes®COMPATIBLE WITH ALL BIOACTIVESNON
DAMAGING
EASE OFFORMULATIONSTABILIZINGSUSTAINED
RELEASE
NO NEED FORPENETRATIONENHANCERS

 

 

Why Hydroxysomes®

Issued Hydroxysome® patents on core technology and applications provide a unique and defensible competitive advantage

 

88% of all API drugs and consumer bio-actives currently do not have any dermal delivery options other than Hydroxysomes® due to incompatible chemistries, molecular weight limitations, or instability issues

Issued Hydroxysome® patents on core technology and applications provide a unique and defensible competitive advantage.

 

 

Limitations of Other Dermal Delivery Technologies:

 Formulation Based:

Add active to cream, ointment or gel and apply: “spray and pray”

Leads to lack of efficacy, poor compliance, irritation potential, high dose frequency

 

Patches; Liposomes; Encapsulation; Devices, and others:

Damaging – Adhesive can irritate skin; often use penetration enhancers

Limiting – Potent drugs with low daily dosage; may have formulation challenges

Inefficient – Small % delivered; excessive loss of  API/Active

 

 

How Hydroxysomes® Work:

 

Hydroxysomes® is co-engineered with active and formulated into conventional topical products, e.g. creams, ointments, lotions.

Upon application, it functions in essence as a “patchless patch” to implement and facilitate enhanced uptake by the skin, and to release high yield active.

 

Sustained Release Skin Delivery:

Hydroxysomes® are not stable at pH below 5: release of API Active is controlled by stratum corneum acidic pH.

Active continues to pass through to the lower epidermis, and/or dermis, and/or systemic flow-through, depending on the characteristics of the active.

Hydroxysomes® particles remain localized in stratum corneum; calcium and
phosphates ions of Hydroxysomes® are slowly absorbed as micronutrients by the skin.

 

  Normal skin as control
with no calcium in SC
           After application,
calcium can be seen in SC
    7 hours after application,
calcium continues to be absorbed

Normal Skin as a Control      Calcium in the SC      Calcium in the SC TEM (27,000X)       TEM (43,000X) * Black Specs Are Calcium       TEM (43,000X)

 

Hydroxysomes® Specifications:

 

Micro-carrier Calcium Phosphate Particles

Porous, Spherical, Rigid Beads

Non-Polymer, Non-Liposome

Average Diameter of 2 µm

Large Surface Area

Highly stable particles

No Nanoparticles

 

 

          

 

 

Key Features:

 

Damage-free/non-invasive

No need for penetration enhancers

Delivery through intact skin

Increased skin penetration

Highly stable, safe and non-toxic

Improved stability of actives

Sustained release

Compatible with almost all bioactives

Increased efficiency/bio-availability

Large scale manufacturing

 

 

Hydroxysomes® Are Safe:

 

TESTCytotoxicityUS-FDANon ToxicMutagenicityAmes TestNon MutagenicSkin SensitizationRIPT (Human)Non IrritatingNon SensitizingMETHODRESULTS

 

 

Development and Licensing:

 

Reformulation strategy with Hydroxysomes® extends patent protection & provides brand evergreening

 

-  LSCTM offers licensing and development opportunity for custom
design co-engineering of Hydroxysomes® with your active

- Stabilization technology for your unstable raw materials

- Encapsulation technology

 

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