GMP-compliant cannabinoid based therapeutic actives

A Deep Dive Into Dronabinol

Dronabinol ((-)-trans-delta-9-tetrahydrocannabinol), is the registered API name for THC naturally present in botanical cannabis (Cannabis sativa L.). The pharmacological actions of dronabinol are modulated by other cannabinoids found in the cannabis plant. Dronabinol preparations can be injected intravenously, topically, or by transdermal delivery methods and taken orally (oral, sublingual, or buccal).

The molecule of dronabinol is either synthesised or naturally extracted, isolated, and prepared to a standardized API in accordance with the monograph. Pharmaceutical medicines like Marinol are then created using this standardised API.

An API – Active Pharmaceutical Ingredient. It is the part of the medication that produces the intended health effects. APIs are produced from raw materials (medical cannabis flowers), with a specified strength (DAC Dronabinol, NLT 95% D9-THC w/w) and chemical concentration (NMT 1.0% CBN, NMT 2.0% D8-THC, Sum Other NMT 3.0%).

Medicines consist of two core components, the API (Dronabinol) and the excipient (MCT Oil, AP). Medicines are produced/formulated with a clinically tested dosage format, for example diluting 2.5% etc. of the API into the carrier oil to represent a dosage per capsule or per ml to deliver 2.5mg of THC based on the therapeutic indication.

As more clinical pharmaceuticals are registered and produced using cannabis derived API’s as, cannabinoid-based medications are proving to be effective against chronic illness. For several decades, pharmaceutical cannabis has been employed in FDA-approved medications that contain synthetic isomers of THC. Cannabis sativa L.-derived cannabinoid compounds used in medical cannabis also show promise in treating several chronic illnesses.

Phytocannabinoids, or naturally occurring cannabinoids, are terpene phenolic chemicals that are generated only by the wildly diverse plant Cannabis sativa L. Since it was discovered that Delta(9)-THC is primarily responsible for the psychoactive effects of cannabis, natural and synthetic cannabinoids have undergone substantial research. In various biological systems, such as the cardiovascular, immunological, and endocrine systems, cannabinoids have pharmacological effects. The majority of these effects have been linked to these substances’ capacity to interact with the CB1 and CB2 cannabinoid receptors. Research interest in these substances has increased as a result of the FDA’s approval of Marinol, a product containing synthetic Delta(9)-THC (dronabinol), in 1985 for the treatment of nausea and vomiting in cancer patients receiving chemotherapy and in 1992 for the treatment of AIDS related wasting where it significantly improves appetite and helps treat weight loss.

An Assistant For Many Health Issues

It can be used to treat a variety of difficult-to-cure disorders. It serves as temporary relief medication for nausea and vomiting. It can be utilised to treat and alleviate chronic pain and has been found to be an effective treatment in neuropathic pain patients.. You might also include post-traumatic stress disorder on the list. In the EU where Dronabinol is used as an API in magistral preparations, the drug is favoured by prescribers, even for offlabel indications based on the greater body of research surrounding it and it’s establishment in the medical sector over decades.

References

[1] Naturally occurring and related synthetic cannabinoids and their potential therapeutic applications

[2] Dronabinol Market Size, Share, Growth, and Industry Analysis

[3] South African Health Products Regulatory Authority

[4] Health professional beliefs, knowledge, and concerns surrounding medicinal cannabis

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5804828/
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CBD Isolate Natural

Parameters
Specification
Formulation
>98% CBD
Appearance
White crystalline powder
Packaging
1kg HDPE container
Storage
Tightly closed, protected from light, 15 - 25° C
Shelf Life
24-months (stability ongoing)
Extraction
Ethanol
Origin
South Africa
Stability Status
Conducted according to ICH stability guidelines
Long term studies up to: 24 months (25°C±2°C, 60% ± 5%RH)
Accelerated studies up to: 6 months (40°C±2°C, 75% ± 5%RH)

Distillate + Strain-Specific Terpenes

Parameters
Specification
Formulation
400-440/800-880 mg THC distillate + Chemovar terpene concentration
Appearance
Yellow-gold viscous liquid, solid at room temperature
Packaging
1ml SS316 or All-Ceramic 10-Thread cartridge
0.5ml SS316 or All-Ceramic 10-Thread cartridge
Storage
Tightly closed, protected from light, 15 - 25° C
Shelf Life
12 months
Extraction
Cryo-ethanol extraction
Low temperature Decarboxylation to preserve terpenes
Origin
South Africa
Stability Status
Conducted according to ICH stability guidelines
Long term studies up to: 12 months (25°C±2°C, 60% ± 5%RH)
Accelerated studies up to: 6 months (40°C±2°C, 75% ± 5%RH)

Distillate + Botanical Terpenes

Parameters
Specification
Formulation
400-440/800-880mg THC distillate + Botanical terpene concentration
Appearance
Yellow-gold viscous liquid, solid at room temperature
Packaging
1ml SS316 or All-Ceramic 10-Thread cartridge
0.5ml SS316 or All-Ceramic 10-Thread cartridge
Storage
Tightly closed, protected from light, 15 - 25° C
Shelf Life
12 months
Extraction
Cryo-ethanol extraction
Low temperature Decarboxylation to preserve terpenes
Origin
South Africa
Stability Status
Conducted according to ICH stability guidelines
Long term studies up to: 12 months (25°C±2°C, 60% ± 5%RH)
Accelerated studies up to: 6 months (40°C±2°C, 75% ± 5%RH)

Live Rosin Strain Specific

Parameters
Specification
Formulation
400/800mg THC Live Rosin concentration
Appearance
Yellow-gold viscous liquid, solid at room temperature
Packaging
1ml All-Ceramic 510-Thread Cartridge
0.5ml All-Ceramic 510-Thread Cartridge
Storage
Tightly closed, protected from light, 15 - 25° C
Shelf Life
12 months
Extraction
EP-grade water and low temperature pressing, fresh frozen cannabis flower
Origin
South Africa
Stability Status
Conducted according to ICH stability guidelines
Long term studies up to: 12 months (25°C±2°C, 60% ± 5%RH)
Accelerated studies up to: 6 months (40°C±2°C, 75% ± 5%RH)

Live Resin Strain Specific

Parameters
Specification
Formulation
400/800mg THC Live Resin concentration
Appearance
Yellow-gold viscous liquid, solid at room temperature
Packaging
1ml All-Ceramic 510-Thread Cartridge
0.5ml All-Ceramic 510-Thread Cartridge
Storage
Tightly closed, protected from light, 15 - 25° C
Shelf Life
12 months
Extraction
Low temperature hydrocarbon, fresh frozen cannabis flower
Origin
South Africa
Stability Status
Conducted according to ICH stability guidelines
Long term studies up to: 12 months (25°C±2°C, 60% ± 5%RH)
Accelerated studies up to: 6 months (40°C±2°C, 75% ± 5%RH)

Full-Spectrum Decarboxylated Crude Oil

Parameters
Specification
Formulation
>70% THC <2% CBD
Appearance
Dark Amber liquid, solid at room temperature
Packaging
Insert Argon purged. Amber glass bottle 50ml, 500ml and 2.5L. Glass Type III Polypropylene (PE) Cap
Storage
Tightly closed, protected from light, 15 - 25° C
Shelf Life
24-months (stability ongoing)
Extraction
Cryo-ethanol extraction
Low temperature Decarboxylation to preserve terpenes
Origin
South Africa
Stability Status
Conducted according to ICH stability guidelines
Long term studies up to: 24 months (25°C±2°C, 60% ± 5%RH)
Accelerated studies up to: 6 months (40°C±2°C, 75% ± 5%RH)
Strains
Black Cherry Punch (Hybrid-Indica), Blueberry Kush (Indica), Critical Kush (Indica), Creamy Kees (Hybrid-Indica), Royal Go- rilla (Hybrid-Sativa), Karel’s Haze (Hybrid-Sativa), Bafokeng Choice-White Lemon (Hybrid-Sativa), UK Cheese (Sativa), Original Blitz (Indica) | *More strains on request

Full-Spectrum Distillate

Parameters
Specification
Formulation
>88% THC <2% CBD
Appearance
Clear yellow-gold viscous liquid, solid at room temperature
Packaging
Insert Argon purged. Amber glass bottle 50ml, 500ml and 2.5L. Glass Type III Polypropylene (PE) Cap
Storage
Tightly closed, protected from light, 15 - 25° C
Shelf Life
24-months (stability ongoing)
Extraction
Cryo-ethanol extraction
Low temperature Decarboxylation to preserve terpenes
Origin
South Africa
Stability Status
Conducted according to ICH stability guidelines
Long term studies up to: 24 months (25°C±2°C, 60% ± 5%RH)
Accelerated studies up to: 6 months (40°C±2°C, 75% ± 5%RH)
Strains
Black Cherry Punch (Hybrid-Indica), Blueberry Kush (Indica), Critical Kush (Indica), Creamy Kees (Hybrid-Indica), Royal Go- rilla (Hybrid-Sativa), Karel’s Haze (Hybrid-Sativa), Bafokeng Choice-White Lemon (Hybrid-Sativa), UK Cheese (Sativa), Original Blitz (Indica)| More strains on request

Live Rosin

Parameters
Specification
Formulation
>70% THC <2% CBD
Appearance
Viscous semi-solid at room temperature, yellow-gold
Packaging
Insert Argon purged. Amber glass bottle 50ml, 500ml and 2.5L. Glass Type III Polypropylene (PE) Cap
Storage
Tightly closed, protected from light, 15 - 25° C
Shelf Life
24-months (stability ongoing)
Extraction
Low temperature EP-grade water, fresh frozen cannabis
Origin
South Africa
Stability Status
Conducted according to ICH stability guidelines
Long term studies up to: 24 months (25°C±2°C, 60% ± 5%RH)
Accelerated studies up to: 6 months (40°C±2°C, 75% ± 5%RH)
Strains
Available on request

Live Resin

Parameters
Specification
Formulation
> 85% THC <2% THC
Appearance
Yellow-gold, semi-solid at room temperature
Packaging
Insert Argon purged. Amber glass bottle 50ml, 500ml and 2.5L. Glass Type III Polypropylene (PE) Cap
Storage
Tightly closed, protected from light, 15 - 25° C
Shelf Life
24-months (stability ongoing)
Extraction
Low temperature hydrocarbon, fresh frozen cannabis flower
Origin
South Africa
Stability Status
Conducted according to ICH stability guidelines
Long term studies up to: 24 months (25°C±2°C, 60% ± 5%RH)
Accelerated studies up to: 6 months (40°C±2°C, 75% ± 5%RH)
Strains
Available on request

D9-THC API (97+%) Natural

Parameters
Specification
Formulation
> 95% THC, minors according to DAC monograph
Product Type
Dronabinol API
Appearance
Clear viscous liquid, solid at room temperature
Packaging
Insert Argon purged. Amber glass bottle 50ml, 500ml and 2.5L. Glass Type III Polypropylene (PE) Cap
Storage
Tightly closed, protected from light, 15 - 25° C
Shelf Life
12-months
Extraction
Solvent extraction
Origin
South Africa
Stability Status
Conducted according to ICH stability guidelines
Long term studies up to: 12 months (25°C±2°C, 60% ± 5%RH)
Accelerated studies up to: 6 months (40°C±2°C, 75% ± 5%RH)

Sativa Strains*

Karels Haze

THC: 30%

Mandarin Cookies

THC: 27%

Original Blitz

THC: 27%

Jungle Pie

THC: 26%

* More available on request

CBD Dominant

100mg/ml CBD <4mg/ml THC – 30ml
Parameters
Specification
Formulation
Full spectrum CBD extract with pharma grade MCT oil
Product Type
MCT oral formulation
Appearance
Clear to amber liquid at room temperature
Packaging
30ml amber dropper bottle with a child-resistant lid and syringe
Storage
Tightly closed, protected from light, 15 - 25° C
Shelf Life
12-months
Extraction
Cryo-ethanol extraction
Origin
South Africa
Stability Status
Conducted according to ICH stability guidelines
Long term studies up to: 24 months (25°C±2°C, 60% ± 5%RH)
Accelerated studies up to: 6 months (40°C±2°C, 75% ± 5%RH)

CBD Dominant

200mg/ml CBD <4mg/ml THC – 30ml
Parameters
Specification
Formulation
Full spectrum CBD extract with pharma grade MCT oil
Product Type
MCT oral formulation
Appearance
Clear to amber liquid at room temperature
Packaging
30ml amber dropper bottle with a child-resistant lid and syringe
Storage
Tightly closed, protected from light, 15 - 25° C
Shelf Life
12-months
Extraction
Cryo-ethanol extraction
Origin
South Africa
Stability Status
Conducted according to ICH stability guidelines
Long term studies up to: 24 months (25°C±2°C, 60% ± 5%RH)
Accelerated studies up to: 6 months (40°C±2°C, 75% ± 5%RH)

CBD Dominant

200mg/ml CBD <ND THC – 30ml

Parameters
Specification
Formulation
CBD isolate with pharma grade MCT oil
Product Type
MCT oral formulation
Appearance
Clear to amber liquid at room temperature
Packaging
30ml amber bottle with glass pipette dropper
Storage
Tightly closed, protected from light, 15 - 25° C
Shelf Life
12-months
Extraction
Cryo-ethanol extraction
Origin
South Africa
Stability Status
Conducted according to ICH stability guidelines
Long term studies up to: 24 months (25°C±2°C, 60% ± 5%RH)
Accelerated studies up to: 6 months (40°C±2°C, 75% ± 5%RH)

Balanced

15mg/ml CBD – 15mg/ml THC – 30ml
Parameters
Specification
Formulation
Full spectrum THC and CBD extract with pharma grade MCT oil
Product Type
Oral MCT formulation
Appearance
Clear to amber liquid at room temperature
Packaging
30ml amber bottle with child-resistant lid and 1ml syringe
Storage
Tightly closed, protected from light, 15 - 25° C
Shelf Life
12-months
Extraction
Cryo-ethanol extraction
Origin
South Africa
Stability Status
Conducted according to ICH stability guidelines
Long term studies up to: 24 months (25°C±2°C, 60% ± 5%RH)
Accelerated studies up to: 6 months (40°C±2°C, 75% ± 5%RH)

Balanced

25mg/ml CBD – 25mg/ml THC – 30ml

Parameters
Specification
Formulation
Full spectrum THC and CBD extract with pharma grade MCT oil
Product Type
Oral MCT formulation
Appearance
Clear to amber liquid at room temperature
Packaging
30ml amber bottle with child-resistant lid and 1ml syringe
Storage
Tightly closed, protected from light, 15 - 25° C
Shelf Life
12-months
Extraction
Cryo-ethanol extraction
Origin
South Africa
Stability Status
Conducted according to ICH stability guidelines
Long term studies up to: 24 months (25°C±2°C, 60% ± 5%RH)
Accelerated studies up to: 6 months (40°C±2°C, 75% ± 5%RH)

THC Dominant

<1mg/ml CBD -15mg/ml THC – 50ml

Parameters
Specification
Formulation
Full spectrum THC extract with pharma grade MCT oil
Product Type
Oral MCT formulation
Appearance
Clear viscous liquid, solid a room temperature
Packaging
50ml amber bottle with child-resistant lid and 1ml syringe
Storage
Tightly closed, protected from light, 15 - 25° C
Shelf Life
12-months
Extraction
Cryo-ethanol extraction
Origin
South Africa
Stability Status
Conducted according to ICH stability guidelines
Long term studies up to: 24 months (25°C±2°C, 60% ± 5%RH)
Accelerated studies up to: 6 months (40°C±2°C, 75% ± 5%RH)

THC Dominant

<1mg/ml CBD – 25mg/ml THC – 30ml
Parameters
Specification
Formulation
> 95% THC, minors according to DAC monograph
Product Type
DAC Dronabinol in oily base, MCT-oil formulated according to NRF 22.8
Appearance
Clear viscous liquid, solid a room temperature
Packaging
Insert Argon purged. Amber glass bottle 50ml, 500ml and 2.5L. Glass Type III Polypropylene (PE) Cap
Storage
Tightly closed, protected from light, 15 - 25° C
Shelf Life
12-months
Extraction
Cryo-ethanol extraction
Chromatography purification
Origin
South Africa
Stability Status
Conducted according to ICH stability guidelines
Long term studies up to: 24 months (25°C±2°C, 60% ± 5%RH)
Accelerated studies up to: 6 months (40°C±2°C, 75% ± 5%RH)

Dronabinol Solution NRF 22.8 25mg/ml

Parameters
Specification
Product Type
DAC Dronabinol in oily base, MCT-Oil Formulated according to NRF 22.8
Formulation
25mg/ml DAC Dronabinol
Appearance
Clear, almost colourless to slightly yellowish viscous solution
Packaging
50ml, 200ml or 500ml amber glass jar Type III, white CR screw cap, magisterial preparation format with TE cap (PP), 2 x THC strip, reaction tube, sterile pipett
Storage
Tightly closed, protected from light, 15 - 25° C
Shelf Life
Ongoing - expected 12 months
Extraction
Solvent extraction and formulation
Origin
South Africa
Stability Status
Conducted according to ICH stability guidelines
Long term studies up to: 24 months (25°C±2°C, 60% ± 5%RH)
Accelerated studies up to: 6 months (40°C±2°C, 75% ± 5%RH)

Indica Strains*

Critical Kush

THC: 25%

Black Cherry Punch

THC: 25%

Blueberry Kush

THC: 24%

Gooseberry Pie

THC: 22%

Chemdog x UK Cheese

THC: 21%

Bubba OG

THC: 20%

Blueberry Muffin

THC: 20%

* More available on request

Hybrid Strains*

Sour OG Cheese

THC: 27%

Royal Gorilla

THC: 25%

White Lemon

THC: 24%

Blunicorn

THC: 20%

Creamy Kees

THC: 20%

UK Cheese

THC: 20%

Orange Velvet Underground

THC: 20%

* More available on request