Introducing Hydroxysomes®

An Innovative Patented Dermal Delivery Platform

exceeding metrics of other dermal delivery technologies

 

 

​TECHNOLOGYHydroxysomes®COMPATIBLE WITH ALL BIOACTIVESNON
DAMAGINGEASE OFFORMULATIONSTABILIZINGSUSTAINED
RELEASENO NEED FORPENETRATIONENHANCERS

 

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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.

 

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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

 

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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

​           TEM (27,000X)       TEM (43,000X) * Black Specs Are Calcium       TEM (43,000X)

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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

 

 

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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

 

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Hydroxysomes® Are Safe:

 

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

 

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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

 

Please contact us for co-engineering development and licensing.