Optimized Advanced Hemp Formulations

How Science Allowed G. Randall & Sons to Improve the Efficiency of Their Formulation by 250%

Randy’s Club is proud to announce a new Advanced Formula Randy’s Remedy Lotion, a scientifically formulated cream, developed in collaboration with our research partners, that has been optimized for the delivery of cannabidiol (CBD) across the skin. CBD is a naturally occurring cannabinoid, found in hemp, that helps support the central nervous system and promotes a healthy inflammatory response.

Before we get to how, let’s talk about why. Why would we bother spending over a year and countless man-hours, tweaking and changing a formulation to better deliver the active ingredients our customers want? The answer is because our mission has always been to develop the best products we wished we had when my father, Randy, was still alive. That meant partnering with the best to develop and optimize our product formulations to be the most efficient and effective products on the market.

GR&S Team Partners with a Contract Research Organization (CRO) to Develop Next-Generation CBD Products.

Our CRO research partners have been dedicated for more than 15 years to the improvement, innovation, and verification of skin-applied formulations. When the formulation scientists, analytical chemists, and permeation professionals begin work with a new active compound, formulation work follows a well-defined process. Their scientists first complete molecular simulation studies to understand the physicochemical characteristics of the active molecule itself. Second, they scrutinize the scientific literature for information that might inform interesting approaches. They refer to their extensive databases of formulations performance that the team has accumulated over more than 15 years of working in the field. And then they bring proven creativity and intuition to bear.

Delivery Varies With Changes In Formulation.

When a formulation is applied to the skin, the amount of the active ingredient (Active) in the formulation that is actually delivered into or through the skin (what is termed the ‘utilization’ of the Active) can vary greatly if the formulation composition is changed. For most skin-applied products the utilization is in the 5% — 15% range. At the low end of this scale, this means that 5% or one-twentieth of the amount of Active in the formulations is available physiologically. For many small molecules, we can predict reasonably well the skin permeation from a saturated solution of the Active in water. Delivery is influenced by the formulation microstructure as well as the effect that components in the formulation have on the barrier function of the skin. These all must be measured. Finally, the driving force for permeation is the effect that the components in the formulation have on the barrier function of the skin. Many formulation ingredients can serve as what are known as ‘molecular penetration enhancers’ or ‘MPE™s’, which improve the ability of Active, such as CBD from hemp, to travel across the surface layer of the skin to the living layers beneath.

An Evidence-Based Approach to a Substantially-improved CBD Topical Formulation.

The extent of delivery of an active ingredient, such as hemp derived cannabidiol (“CBD”), from a formulation that is applied to the skin can vary greatly as the formulation composition and format is changed. Most of the CBD in any formulation remains on the skin exterior; for some formulations essentially all of the CBD will remain on the exterior. No one can predict how well CBD will be delivered from a given formulation unless the extent of CBD delivered is actually measured. If such measurements have not been made on a CBD formulation, it is pure speculation as to how much of the CBD, if any, is actually delivered usefully into or through the skin.

The CBD may not be ‘released’ from the formulation to the skin surface. The function of the skin barrier is to prevent most molecules from entering or exiting through the skin. To achieve a useful level of CBD delivery, therefore, we need to engineer the release of CBD and selectively permeabilize the skin barrier for CBD. Permeation measurements using a synthetic membrane or even with a live skin culture are generally not predictive of what happens in live skin (that is, in vivo). To be reliable, delivery measurements must be made on real skin.

Other Factors Are Also Important In Determining Product Appeal

While achieving the desired level of delivery is usually the most challenging when developing a skin-applied product, to be viable and appealing three other factors are also important.

1. The product must be stable. Over a reasonable shelf-life, it is a requirement that the product is stable physically, that it does not phase separate or otherwise change physical form.
2. The formulation must also have reasonable chemical stability. Neither hemp derived CBD, nor indeed any of the other formulation components, can degrade substantially over storage and use conditions.
3. The formulation must have an aesthetic appeal. A skin-applied product will lack appeal if it has an unpleasant appearance, color or odor. The ‘aesthetics’ of the product, that is, the sensations that accompany application of the product to the skin are also important.

Traditional approaches for assessing formulation esthetics using volunteer panels have been notoriously subjective. Our partners have developed a proprietary approach to esthetics panels for topical products that appears to be a step towards improved objectivity.

Choosing Ingredients For Optimal Benefit.

The bulk of the formulation is made up of inactive ingredients, termed excipients. The specific combination of excipients must satisfy the above CBD delivery, stability and esthetics requirements. It is also important that they cause no untoward physiological effects. The formulation cannot be irritating or sensitizing to the skin. Any risk of triggering an allergic response also needs to be avoided. Our research partner circumvents these potential problems by incorporating only specially selected excipients. They have compiled a proprietary database of 17,072 distinct materials that are used in cosmetic products, 4,466 of which are unique molecular entities. These are compiled from the excipients listed on the ‘generally regarded as safe’ or “GRAS” list. The FDA inactive ingredient database (“IID”) comprises excipients that are used in products for topical or transdermal administration that have been approved by the FDA. A consumer will have the least concern about the excipients used in a topical CBD product when all are listed on the IID for topical or transdermal administration and used within the compositional limits provided in the IID.

Randy’s Remedy Advanced Formula Lotions

GR&S established a formal collaboration with our CRO research partners to work with the Strause Group to develop novel formulations to deliver cannabinoid profiles across the skin and mucosa. These research scientists devised approximately 150 different formulation compositions containing cannabidiol (“CBD”). Each of these formulations was prepared, assessed for their stability and appearance, and the extent of delivery of CBD from each into and through human skin was measured. As a benchmark for these various measurements, Randy’s Remedy Lotion, a cream formulation that has been very well received by our customers, was chosen. Randy’s Remedy Lotion is already a strongly-performing product, with broad market adoption and sold in an airless pump. However, the potent combination of proprietary technologies, detailed knowledge of topical formulations, and honed creativity, enabled their scientists to identify a number of formulation compositions that provide the sought-after next-generation delivery performance.

This initial collaboration has led us to Randy’s Remedy Advanced Formula Lotion. We chose “advanced formula” because the data showed a 250% improvement in permeability through the skin. Watch for this months launch of our Advanced Formula Everyday Lotion and our Advanced Formula Extra Strength Lotion, both in scented and unscented options. We promise that both advanced formula products will provide you with the results you received from our Randy’s Remedy Lotion and perhaps, a ‘little bit more’!