Building a Successful CBD Practice in Your Pharmacy
←
→
Page content transcription
If your browser does not render page correctly, please read the page content below
9/9/2021
Building a Successful CBD
Practice in Your Pharmacy
ACPE # 0130‐9999‐21‐294‐L04‐P&T
D. H. John Kim, Pharm.D., FAARFM
Compounding Pharmacist / Functional Medicine Specialist
Robinson Drug & Compounding Center (Mendham, NJ)
Email: John@robinsondrugshop.com
Instagram: @dr.john.pharmd
1
Financial Disclosure
Dr. John Kim is an owner of Robinson Drug & Compounding Center in
Mendham, NJ
Chief Scientific Officer of Imbue Botanicals CBD Company
2
1
9/9/2021
BIO
Graduated with Cum Laude at Ernest Mario School of Pharmacy – Rutgers, The
State University of New Jersey
Fellow in Anti-Aging and Functional/Regenerative Medicine (A4M) (FAARFM)
Specializing in pharmaceutical and cosmetic formulation
Hormone replacement therapy, pain management, vector borne illness,
mycotoxin, autoimmune disorder, Phyto-cannabinoid medicine
3
Objectives
1. Discuss History and Overview of Cannabis in pharmacy
2. Differences among hemp, marijuana, and other cannabis derivatives
3. What are the Chemical Substances in the Cannabis Sativa Plant and
pharmacology of Cannabidiol (CBD)
4. What type of forms of use do pharmacists have to know? - dosage
forms and different modes of delivery
5. Extraction Science - Ethanol Extraction VS CO2 Extraction
6. Discuss the indication of uses (Common issues pharmacists see within
the community)
7. Finding the right dosage in CBD isolates vs. Full Spectrum Extract CBD
8. How to choose the right CBD company and why this is so important?
9. How to implement a successful CBD program in your pharmacy
4
2
9/9/2021
HISTORY
5
History of Cannabis sativa
Earliest robust evidence of human cannabis use dates from the Copper Age
(4600~3600 BCE in Moldovia, Romania, and Bulgaria) and Bronze Age (3400 ~
3200 BCE in southeastern Europe
First recorded medical use of cannabis – Emperor Shen Nong from 2700 BCE
Transcribed in 2nd century CE in Shen Nong Ben Cao Jing – noting hallucinatory
effects, appetite stimulation, tonic and anti-senility effect
Ancient Egypt – cannabis used for vaginal contractions and ophthalmological
condition
Greek physician – Dioscorides – used cannabis for earache in 1st century CE
6
3
9/9/2021
History
THC dominant cannabis found in Yanghai Tombs in Xinjiang, China (700 BCE)
Chinese description of Cannabis
Male – Superior for fiber
Female – Superior for intoxication – indicating presence of THC
content
Modern History
- Irish physician William O’Shaughnessy – learned about “gunjah” in India.
- Studied literature and described various preparation, evaluated its toxicity
in animals and reported side effects
- Medical cannabis spread through Europe and North America
- 1854 – The Dispensatory of the United States of America
- Over 100 scientific articles were published in Europe and the United
States about therapeutic value of cannabis
- Late 19th and early 20th Century – numerous pharmaceutical
companies marketed cannabis
- Merck, Bristol Myers Squibb, Parke Davis, and Eli Lilly
7
Cannabis
sativa
8
4
9/9/2021
Cannabis sativa L.
Family Cannabaceae – Closest relative is Humulus which
produces a female flower known as hops – widely used as a
flavor and aroma ingredient of beer
Medicinal compounds in cannabis are produced in trichomes,
a glandular protuberances that grow on the leaves and
flowers and less extent on the bracts and stems of female
plants
Trichomes – Produce resin rich Phyto-cannabinoids and
terpenoids (provides a strong aroma, repels insects,
and potentially suppress other surrounding vegetation
Resin – provides antibiotic and antifungal properties
and protect against water loss
Anti-oxidant activity – helps to protect plants from
ultraviolet (UV) radiation and oxidative stress
Contains more than 160 cannabinoids (ie. CBD, THCA,
CBN, CBG, CBC, CBDV, THCV, Delta 8 and Delta 9, etc)
580 natural compounds have been identified in
cannabis
Still don’t know Little to nothing about
pharmacological effect for a lot of compounds in a
cannabis plant
9
Cannabis sativa L.
Chemical composition of plant will vary from:
Environment
Increased cannabinoid production associated with low humidity, sparse rainfall,
increase UV radiation, soil nutrient (magnesium and iron) and parasites
Soil microbiome (bacteria) – influences the quality of the plant
Cannabis flowers can contain potential pathogenic microbes
Several toxigenic fungi – Penicillium and Aspergillus species
This can be detrimental to immunocompromised patients associated with cannabis
inhalation
Method of sterilization is developed
Checking microbial testing on the finished cannabis/CBD product is a must
10
5
9/9/2021
Medical varieties of Cannabis
Type 1 – THC dominant
Type 2 – both THC and Cannabidiol (CBD)
Type 3 – CBD Dominant
Recently – Hemp – grown for non-medical crops
Cannabis Varieties including fiber, herd (center of stalk) and seed
Regulation of 0.3% (W/W) THC- content
Type 3 CBD rich flowers with ultra low THC
content – to be qualified as a hemp product
Strains of Cannabis
Type 1 – Sativa
Type 2 – Hybrid
Type 3 – Indica
11
Endocannabinoid
System
- Master system
12
6
9/9/2021
Endocannabinoid
System (ECS)
Located in the mammalian central
nervous system (brain and spinal cord)
and peripheral nervous system (nerves
/ ganglia outside of the brain and spinal
cord)
Regulates various physiological and
cognitive process – appetite, pain
sensation, mood, fertility, pregnancy,
during pre-and post-natal development,
and in mediating the pharmacological
effects of cannabis
ECS – Consists of endocannabinoids,
cannabinoid receptors and enzymes
responsible for synthesis and
degradation of endocannabinoids
Anandamide (AEA)
2-arachidonoyl glycerol (2-AG)
13
ECS
Harmony = Homeostasis and
immune system – stability,
balance, or equilibrium within a
cell or the body
Sense of bliss, joy, subsiding both
physical and emotional pain
CBD – Emotionally elevated –
Enhances the quality of life
Endocannabinoid System
CB1 and CB2 Receptor – 2 main
receptors (G-Protein Coupled
Receptors (GPCR)
CB1 – Located primarily in the
CNS
CB2 – Primarily
immunomodulatory and found in
periphery (i.e.. Organs)
14
7
9/9/2021
15
16
8
9/9/2021
17
ECS
Both THC and CBD – compete to bind to the CB1 receptor
THC – potential partial agonist and orthosteric binder – resulting in euphoria and
other psychotropic effect
CBD – Negative allosteric modulator – Alters the shape of the CB1 receptor and
reduces binding ability of THC – i.e.. THC overdose – high concentrated CBD can be
used in an emergency medicine setting
Cannabinoids binding to receptors to produce agonist or antagonist response
Agonist – cause euphoria, hunger, or thirst (cotton mouth)
Antagonist – produce complete opposite response
DK1
18
9
Slide 18 DK1 Dou Kim, 9/6/2021
9/9/2021
Cannabidiol
19
Cannabidiol (CBD)
65 distinctive pharmacological
target for cannabidiol (In Vitro
studies) including receptors, ion
channels, and enzymes, and
transporters
Strong pleotropic – many immune,
physiological modulating activity
exert by CBD
Remarkably safe and well-
tolerated
Chronic use and high doses up
to 1500mg/day of CBD are
reportedly well-tolerated in
humans
20
109/9/2021
Pharmacology of CBD
Stimulation of serotonin 5-HT1A receptors – common mechanism for reducing anxiety,
reduce the damage of brain ischemia, reducing nausea, and improve cognition In
hepatic encephalopathy
Common MOA for anxiolytic and antidepressants for targeting 5-HT1A receptors
5-HT1A – Improves cognition, decreases aggression, increases sociability,
decreased impulsivity, inhibit drug seeking behavior, and facilitate sex drive and
arousal
Adenosine receptors – Regulate heart function, inflammation, and dopamine and
glutamate release in brain
CBD stimulates adenosine A1 receptor – this has been shown to prevent irregular
heart rhythm in rodent model of heart attack
Anti-inflammatory and potential neuroprotective effect
21
Pharmacology of CBD
Glycine receptor - Modulate neuropathic pain and inflammation
Targeting alpha-glycine receptor to reduce chronic inflammatory pain caused by noxious
heat stimulation
Antispasmodic effect
Dopamine Receptor – Partial agonist at the dopamine D2 receptor
Antipsychotic effect at high doses in humans
Similar biphasic effects as dopamine partial agonist medication – aripiprazole
GPR55 – anti-inflammatory effect – reduce neuronal excitability via GPR55
antagonism
Ion Channels – agonist at transient receptor potential vanilloid type 1 (TRPV1) –
mechanism of analgesic, anti-inflammatory and anti-epileptic effects and
contribute to its anti-psychotic effects
Commonly used in topical preparation
Voltage dependent anion selective channel 1 (VDAC1) – helps to modulate cellular
energy, calcium homeostasis, apoptosis, and protection against oxidative stress
Transporters and enzymes – CBD prevents reuptake of several neurotransmitters
including norepinephrine, dopamine, serotonin, GABA, and anandamide
22
119/9/2021
Phytocannabinoid
pharmacology
Entourage Effect – Phyto
cannabinoids (found in trace
quantities) can produce
synergistic pharmacological
effects with well-known counter
parts
Phytoconstituent synergy is the
rule of cannabis-derived
medicine – Contributes to diverse
therapeutic effect and potential
clinical application
23
Highlight of Entourage Effect
Randomized controlled trial of patients with intractable pain
Whole Plant extract (CBD and THC) vs synthetic THC
Whole plant did better at pain control
Animal model study – Full spectrum extract of cannabis (rich in CBD and other
Cannabinoids and low in THC) – produced linear dose response
Breast Cancer study – (tissue culture) – Combination of CBG and THCA showed
better results treating the tumor compared to single THC extract
24
129/9/2021
Terpene profile
25
CBD
Products
26
139/9/2021
Available forms of
CBD Products
Full Spectrum – Provides the full
entourage effect for a great
synergistic therapeutical value to
your CB1
Broad Spectrum – THC removed
(Ideal for clients getting drug
tested)
Isolate – Single cannabinoid (i.e..
CBD, CBG, CBN, THCA, THCV,
CBDV)
27
Extraction Science
CO2 Extraction vs Ethanol extraction – Main question to ask is what are you
trying to produce?
There is no perfect extraction method and there are advantages and
disadvantages of both extraction process
Ethanol Extraction – One of the oldest way of extracting – Record of ethanol-
based cannabis tinctures being sold in apothecaries in the United States until
1937 when cannabis was outlawed
CO2 Extraction – Method invented by the Nazis to extracting oil from shale for
the war. – Large scale CO2 has been repurposed for the beer industry to
extract hops (relative of cannabis plant)
28
149/9/2021
Extraction science
CO2 Extraction Ethanol Extraction
Uses carbon dioxide – requires correct temperature and Alcohol used as a solvent – cleanest and safest
pressure conditions solvents compared to butane
Clean/Safe - CO2 is non-polar and non-water soluble No residual residue present – ethanol is
completely and easily evaporated
Very picky – Fails to extract much of the beneficial Highly Efficient extraction – POLAR IN NATURE –
phytochemicals present in cannabis resin (As a results – bonds with water- and fat-soluble plant
CO2 extraction requires ethanol use during final process compounds including fatty acids, terpenes and
to capture lost phytochemicals Phyto cannabinoids (Purifying hemp resin)
Drastically changes chemical composition of cannabis Excellent choice for full spectrum extract – Best
strain – eliminates subtle flavor and aroma molecules for producing hemp oil for health and wellness
(due to different phase (liquid to gas) changes purpose
Produces a different product compared to ethanol Pulls away all plant material – tend have darker
extraction green color and more bitter taste
Ideal for consumers looking for isolate cannabinoids or Ethanol can be recirculated during extraction
pure form of cannabinoids process to ensure optimal extraction of essential
oil (Most efficient extraction)
Light to dark amber in color – honey like texture Dark amber coloration – syrupy in texture
29
Dosage
Form
30
159/9/2021
Available Forms for Use
Route of Administration:
Tinctures – Use of carrier oil like MCT Oil, coconut oil, olive oil
When full spectrum oil Is mixed with carrier oil – the bitterness must be
masked
Capsules – Slowest onset of delivery and must pass through 1st pass metabolism
in the liver. Therapeutic effect is the longest
Gummies – Provide both mucosal and gut absorption
Topical Cream / Lotion / Ointment – This will provide local treatment for pain
and dermatological issues
Systemic absorption is not possible
Vapor Cartridges – Quickest on-set of delivery through the lungs into
bloodstream
Potential issues dealing with volatile gas from propylene glycol or another
cutting agent
31
Available dosage form
Kief – Trichomes and terpenes are sifted through a fine mesh screens and yield
collection of trichomes
Usually these are raw form of flower and needs to be smoked, vaporized or
decarboxylated to convert from CBDA to CBD
Bubble Hash
Using ice water – separate trichomes from the plant material
Cannabis Concentrates – CBD flower resin – Concentrate of CBD and/or other
cannabinoids are pressed with high pressure will separate the resin
CBD Rosin
32
169/9/2021
Indications for
CBD
33
Indication
34
179/9/2021
Indication
Epilepsy and seizure disorders
Studies since 1970s as anti-seizure and anti-epileptic compound
FDA approved product – EPIDIOLEX – approved in 2018 – indicated for rare diseases for
Dravet Syndrome and Lennox-Gastaut Syndrome (Childhood seizure disorder)
Mechanism unknown – May act by modulating endogenous systems such as neuronal
inhibition, intracellular calcium and adenosine modulation
Sleep and Anxiety
Large Case study – 79.2% (57 out of 72) of patients had decreased anxiety score and
sleep complaints 66.7% patients (48 out of 72) had improved sleep in the first month
Public Speaking – Reverse Anxiogenic effect of THC and reduced anxiety.
May be used as an adjuvant in anxiety disorder
PTSD – CBD shown to modulate fear memory formation through interaction with
serotonergic Transmission in the mesolimbic system ( Norris et al. – Neuropsychology.
(2016)- 41, 2839-2950
35
Inflammation and Immune modulation
Inflammation – Body’s own mechanism to stimulate immune response and
designed to protect the body from disease
Disruption of functionality leads into autoimmune disease – rheumatoid
arthritis, lupus, celiac disease, and psoriatic arthritis
CBD has been shown to balance and demonstrate immunosuppressive effect and
shown to inhibit the formation of keratinocytes that are typical for psoriatic
arthritis
36
189/9/2021
Cancer
Cancer – gene mutation, cellular damage, immune mediated responses,
inflammation
Many cannabinoids (i.e.. CBD, CBG, CBN, THC) shown to have various anti-
cancer characteristic including anti-proliferative, and pro-apoptotic
properties
Effects of CBD on numerous cancer cell lines (in-vivo and in-vitro)
Breast carcinoma, prostate carcinoma, colorectal carcinoma, skin cancer,
pancreatic cancer, lung cancer, and bone cancer
Future – CBD could be used as an adjunctive therapy to target cancer cell lines
which can ultimately reduce side effects many patients experience when
undergoing chemotherapy and radiation treatment
37
Neuroprotective and Neurodegerative
Disease
Alzheimer’s, Parkinson’s, and Huntington’s
CBD has been shown to exert neuroprotective, anti-oxidative, and anti-apoptotic
effects
Shown to inhibit neurotoxicity of beta amyloid peptides in mouse models in vivo
Slowing progression of Alzheimer’s Disease
Shown to also decrease copper-zinc enzyme which can lead to additional signs of oxidative
United States Department of Health and Human Services hold a patent titled –
Cannabinoid as Antioxidants and Neuroprotectants
38
199/9/2021
Anticonvulsive
Antiinflammatory
Conclusion: Analgesic
Antioxidant
Cannabidiol: Antifibrotic
Physiological Anxiolytic
Activity Antipsychotic
Procognitive
Neuroprotective
39
Dosing on
CBD
40
209/9/2021
Dosing
Varies from product to product, type
of extraction process used, where it
has grown, how it is processed
CBD Isolate – Narrow therapeutic
window (Bell Curve response when
administered)
Full Spectrum – Tend to show direct
response between dose increase (no
upper limit or hitting a “response
plateau”)
Coming from the Entourage effect
Full spectrum oil – Patients able to
take higher dosage and titrate
rapidly as risk of overshooting dose
for therapeutic response is less.
Patients must go through a process
of trial and error to find the correct
dose
Dose depended on the condition we
are targeting for the patient
41
How to market CBD into your
community?
42
219/9/2021
Marketing: Healthcare Professionals
Direct Marketing to Doctor’s Office – Find out who your local medical
marijuana licensees are – Directly market to them first
Cross hybridization of cannabis caused high yield of 9-delta-tetrahydrocannabidiol
(THC) – Cause high side effects
Pain specialists, Rheumatologist, Gastroenterologist, Neurologists,
Functional/Integrative Specialists, Infectious Disease (treating vector borne
illness)
Know your science on CBD – Understanding of endocannabinoid system is very
important
Become the community highly sought after Phyto-cannabinoid specialist.
43
Marketing: Patient/Support Group
Patient seminar – Monthly
Upselling CBD products to patients who are on opioids, SSRIs, compounded
low dose naltrexone, immune modulators (i.e. Humira, Methotrexate) – CBD
capsules /tinctures
Any patients that are on topical eczema/psoriasis products – Recommend
CBD Salves
Beauty Cream
Facebook support group – LDN (Low Dose Naltrexone) patient group page,
Chronic Illness Page, etc.
Instagram Page – Direct consumer education - @Dr.John.PharmD
Online Retail Store
44
229/9/2021
Why Pharmacists Should Get Involved in
Phyto-Cannabinoid Medicine
Selecting right dosage form of Full Spectrum CBD (ie. Capsules, tinctures, salves,
lotions, gummies and vapors) can be complex to consumers – Pharmacists should
be in the forefront.
Patients who seek hemp-based CBD products already suffer from complex
conditions such as chronic pain, auto-immune disorders and other individualized
aliments.
Pharmacists are the most accessible healthcare professionals that can consult
with the patient
Pharmacists can work with patients and physicians to provide a triad-relationship
to bring optimal therapeutic options along with compounded medications to
better their overall health and wellness
45
Why Pharmacists Should Get Involved
If you are in the compounding business:
Low Dose Naltrexone Therapy – Endorphin system is complimentary to the
Endocannabinoid system – Enhances the effectiveness of CBD by the LDN – Seen in
managing pain, autoimmune disorders, cancer, etc.
46
239/9/2021
What to look for in a CBD company
Sourcing of high quality hemp – Where does the company grow their hemp?
How is it grown? Organic? Sustainable growing process?
Extraction process of hemp and testing of raw hemp (hemp is a bio-
accumulator)
Rigorous third-party testing to ensure potency (guaranteeing the strength and
terpene profile) and it is safe for your patients (ie. heavy metal testing,
solvent testing, microbial/mycotoxin testing, insecticides and other
contaminants)
Where do they manufacture their finished products? Who is their processing
company? Are they “white labeling” their products?
CBD company should be committed to delivering clinical-grade products that
are sold by healthcare professionals
Company does not produce or sell inhalable products
Strong customer service and education support for wholesale customers
Product development backed by science, innovation and research.
47
Conclusion
D. H. John Kim, Pharm.D., FAARFM
Compounding Pharmacist / Functional Medicine
Specialist
Robinson Drug & Compounding Center (Mendham, NJ)
Email: John@robinsondrugshop.com
Instagram: @dr.john.pharmd
48
249/9/2021
You Must Submit a Completed
Evaluation Form for This Session
to Receive CE Credit
Please go online to https://www.surveymonkey.com/r/VFCHC9M and
complete the short evaluation for this session.
YOU HAVE 5 DAYS TO COMPLETE THE EVALUATION. THE EVALUATION
LINK WILL DEACTIVATE AFTER 5 DAYS AND NO EVALUATIONS WILL BE
ACCEPTED AFTER THAT TIME.
49
25You can also read
