Standardised recipes in accordance with DAC/NRF

Standardised recipes based on the New Formulation Form (NRF) are available for the preparation of cannabinoid drugs.

inhalation

• Cannabis flowers for inhalation after evaporation (NRF 22.12.)
• Cannabis flowers in single doses for inhalation after evaporation (NRF 22.13.)
• Ethanolic dronabinol solution 10 mg/ml for inhalation (NRF 22.16.)

Oral ingestion

• Cannabis flowers for tea preparation (NRF 22.14.)
• Single-dose cannabis flowers for tea preparation (NRF 22.15.)
• Dronabinol capsules 2.5 mg/5 mg/10 mg (NRF 22.7.)
• Oily dronabinol drops 25 mg/ml (NRF 22.8.)
• Oily cannabidiol solution 50 mg/ml — 400 mg/ml (NRF 22.10.)
• Cannabidiol capsules 10 — 250 mg (NRF 22.17.)

Alternative, non-standard recipes

In addition to the recipes standardized in the DAC/NRF, it is possible to produce other non-standardized preparations in accordance with §7 Apothekenbetriebsordnung. This paragraph regulates the manufacture of prescription drugs and states that they must comply with medical prescription.

• In this context, the documentation of the plausibility check, the manufacturing instruction and the manufacturing report is important.
• When producing THC-containing recipes, a production-related deviation of up to 10% between the quantity dispensed and the actual quantity used is understandable.
• Individual testing of the substance is required before the start of production.

Formula of hard capsules containing cannabis extract

Encapsulating cannabis extracts can increase compliance by simplifying dosing and intake.

• Particularly suitable for patients with motor or visual disabilities (e.g. geriatric patients).
• Suitable for patients with sensitivity to the smell and/or taste of cannabis extracts.

Recipe summary

Oriented to: NRF 22.7, 22.17 and stock preparation p. 44

recipe example

Preparation: Preparation of a lipophilic melt

1. Preparing the capsules
   • Open capsule shells using a capsule board.
2. Cannabis extract blend
   • Mix cannabis extract in a beaker with the required amount of palmitoylascorbic acid to a homogeneous mass so that there are no powder nests or agglomerates.
3. Heat MCT oil
   • Liquefy MCT oil at a maximum of 70°C.
4. Emulsify
   • Add polyoxyethylated castor oil to the cannabis extract palmitoylascorbic acid mixture and mix thoroughly until a homogeneous solution is obtained.
5. Create the lipophilic melt
   • Add melted hard fat to produce the lipophilic melt. If necessary, also heat the extract mixture slightly to avoid phase formation.
6. Fill the capsules
   • Using a wide-beam cannula and disposable syringe, fill the lower parts of the capsule evenly up to the top edge (flat or slightly concave surface) with the melt.
7. hardening
   • Let the filled capsules harden for about 30 minutes. Do not refill the space created by volume contraction to avoid a possible overdose.
8. Capping and weighing
   • Seal capsules

Formulation for various capsule thicknesses

2.5mg THC/capsule

End process control

The capsule surface must be free from melt residues.

The uniformity of the mass is tested in accordance with Ph.Eur. 2.9.5. For this purpose, either the individual capsules are weighed or the total weight of 20 capsules is determined and the average mass is calculated. For a maximum of 2 of the 20 capsules (≥ 300 mg net mass), the individual mass of the content may differ by more than 7.5% from the average mass, but no capsule may differ by more than 15%. The calculation aid “Melt-filled hard capsules: batch calculation and in-process tests” (DAC/NRF tools) can be used to check uniformity and mass-correctness.

Filling, packaging and storage

The capsules are filled into suitable containers immediately after preparation. The following child-resistant packaging materials are suitable:

• Wide mouth amber glass bottle (75 ml, 100 ml or 125 ml)
• HDPE square bottle
• plastic container with push-screw closure

labeling

The formula produced must be labelled in accordance with the requirements of the pharmacy operating regulations.

Approval

The approval test is carried out by a pharmacist and is signed in the manufacturing report. The capsules must not have any deformations. If a child-resistant container is used, its functionality must be checked.

warehousing

The hard capsules should be kept tightly sealed, protected from light, at room temperature (< 25 °C) and out of the reach of children.

Expiry period

Based on NRF formula 22.7., a processing period of 6 months can be accepted.