Enhanced delivery methods for greater efficacy

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1 On-Line Formulation Training - Anywhere In The World - Enhanced delivery methods for greater efficacy Belinda Carli Director, Institute of Personal Care Science

2 Image showing absorbance in the outer stratum corneum only; for example, D&C colourant staining Image showing absorption into the intracellular space at around the stratum granulosum level substances must be quite small and in a suitable medium to traverse to this level Image showing absorption into the intracellular space to the stratum basale level substances must be extremely small and in a suitable medium to traverse to this level

3 Particular Size nm (10-9 m) Size microns (10 - Stratum corneum hydrophilic pathways m) Cell membrane Stratum corneum lipid bilayer Stratum corneum intercorneocyte space Stratum corneum thickness 10,000-40, Human hair diameter 80,000 80

4 Solvent delivery Skin is largely hydrophobic water will bead or sit on surface of skin with little penetration Hydrophilic pathways into cells = 0.4nm How to get actives across? reduce polarity index of skin increases absorption of water soluble substances osmolytic pathways uses osmosis (concentration gradient) to pull hydrophilic substances into deeper layers of skin

5 Solvent delivery Reduce polarity index: dimethyl isosorbide (DMI) First used for pharmaceutical delivery Now used increasingly in cosmetics PI: normal skin approx. zero DMI PI = 7 water soluble actives approx. 8 +

6 Solvent delivery Action: DMI permeates upper layers of skin but does not disrupt stratum corneum raises PI of skin making it more compatible with water soluble actives increases solubility of penetrating molecule into the skin reduces water solubility of some water soluble actives which helps force active out of product into skin on application

7 Solvent delivery

8 Solvent delivery DMI can be used for: water soluble actives (DMI insoluble) difficult to dissolve actives oil soluble actives water soluble actives (DMI soluble) To incorporate into formulations: generally add DMI to water phase unless dissolving water soluble active if water soluble active, dissolve active in DMI first then add to water phase

9 Solvent delivery Osmolytes: osmolytes travel into deeper layers of skin (up to stratum granulosum) due to concentration gradient (osmosis) improves water balance in skin allows passage of water soluble substances do not interfere with cellular mechanisms do not upset electrostatic balance of the cell do not perturb cellular structures Examples: methylamines eg betaine polyols eg glycerine, propylene glycol, butylene glycol, pentylene glycol amino acids and their derivatives

10 Solvent delivery To use: pre-disperse active into osmolyte then add to water often come pre-blended Clinical efficacy (betaine): influences deeper moisturisation water balance of skin protects against irritation increase fibroblast growth and collagen production reduces stickiness in formulations

11 Liposomes Spherical vesicles composed of phosphatidylcholine bilayer membranes May be one or more bilayers Typically nm (can be nm) Interact with skin: adsorption and fusion on the surface of the skin leading to increased thermodynamic activity and enhanced penetration of lipophilic substances interaction of the vesicles within the deeper layers of the stratum corneum enabling delivery of the substance conditioning for the skin

12 Liposomes Can hold hydrophilic and amphiphilic substances Limited lipophilic content Can release their content slow and controlled, due to the longer contact time and compatibilities of liposome with skin Enhance penetration due to similarities with cell membranes Low toxicity and non-allergenic Enhance stability of internal actives Create your own liposomes:

13 Micro and nano-encapsulation Micro-encapsulation: where very thin coatings of polymeric materials are deposited around microsized particles of solids or droplets of liquids often use wax to enhance stability of outer shell may not be shell but homogenous structure typically µm with 10-90% wt core

14 Micro and nano-encapsulation Used to: enhance delivery through small size and compatibility of phases with skin separate incompatible substances enhance stability of internal phase components controlled release of internal actives delivers lipophilic and hydrophilic substances enhance trans-follicular delivery

15 Micro and nano-encapsulation Benefits: enhanced aesthetic effect sustained/slow release stabilisation of actives solution for ingredient incompatibilities prolonged shelf life of final products covering/masking of specific physico-chemical properties (odour) visual effects

16 Micro and nano-encapsulation Nano-encapsulation: similar to micro-encapsulation but < 1µm may not use polymer shell Formed: emulsification: solution, phase inversion, polymers desalvation: polymers, nanocapsules polyalkylcyanoacrylate nanocapsules

17 Micro and nano-encapsulation Capsule must be inert to core material strength to allow for normal handling without rupture shell/matrix: thin enough to permit a high core volume to polymer ratio gelatin/gum arabic/carboxymethylcellulose/agar/alginate/ethylcellulose polymeric materials waxes inner core: actives, fragrance, colour etc

18 Micro and nano-encapsulation Manufacturing considerations: low temperatures (at or near room temperature) low shear care when filling! sufficiently high yield value to hold in suspension

19 Micro and nanoemulsions Micro and nanoemulsions: composed of water, oil, amphiphile microemulsions: < 1µm; blue-grey appearance nanoemulsions: nm; gel-like/clear; swollen solubilised micelles greatly improve bioavailability may be solid or liquid lipid or lipophilic substance eg vitamin A, holding active monolayer of surfactants used to stabilise droplet stable toward addition of surfactants later (more so than liposomes)

20 Micro and nanoemulsions Advantages: can incorporate or solubilise active substances improve skin penetration and permeation useful for dermal and transdermal delivery more transdermal delivery of lipophilic penetrate = faster delivery/faster efficacy more dermal delivery of the hydrophilic penetrate = more delivery/more efficac Disadvantages: increase skin irritation and sensitization due to high surfactant content need to be careful of enhanced delivery and efficacy: may need to reduce dose of active may need to use clinically proven/tested ingredients must be safe!

21 Micro and nanoemulsions To form: dissolve water-soluble ingredients in aqueous phase and oil soluble ingredients in oil phase oil and water phases emulsified using high shear and high temperatures (70-80 C) resulting emulsion then rapidly cooled and homogenized into a fine monodispersed emulsion phase inversion also useful Some actives come as nano-emulsions

22 Performance and safety Cosmetics must not contain pharmacologically active substances or alter the structure or function of the human body Use is restricted to appearance or odour of the external parts of the body (and mucous membranes) Enhanced delivery systems enable deeper delivery of actives only permitted where active does not cause systemic, physiological or pharmacological effect MUST BE SAFE!

23 Performance and safety With enhanced delivery: more active in skin greater efficacy of active more risk for adverse events Test for safety Refer to suppliers documentation Reduce input of active less active = same results same active = better results (if proven safety)

24 Performance and safety Discussion topics: increased permeation still restricted by size of molecules tests for efficacy increased penetration coupled with surfactants disturbance of stratum corneum? Risk of irritation? increased permeation with dyes potential for increased irritation? testing essential increased permeation with preservatives potential for increased irritation? choose mild preservatives and conduct testing

25 Which type of delivery system? Site of application eg sensitive, thin skin, hair etc Area of application large or small area to cover Target site uppermost stratum corneum or viable epidermis Sensory properties light cream or heavier emulsion Optical aspects clear, transparent, milky, mono- or multiphasic State of matter liquid, semisolid or solid Hydrophilic nature of active hydrophilic or lipophilic Storage and stability Manufacturing capabilities Packaging Competitor products

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28 Questions? Comments? LEADERS in DISTANCE and ON-LINE training Certificate and Diploma level We bring the training to YOU Flexible study at your home or work See us on YouTube

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