NegEnt Galenico Magistrale

Galenic medicinal products are defined as those prepared by pharmacists in the laboratory of their own duly equipped pharmacy. They differ, in terms of the regulations governing their sale to patients, from the medicines packaged by pharmaceutical companies which, in order to be marketed, require authorisation, which in Italy is issued by the Italian Medicines Agency (AIFA).

It is important to note that the registration process for a new drug involves an investment of more than one million euros for a pharmaceutical company and an average of about ten years for studies and research.

The only registered Cannabidiol-based drug with both the US Food and Drugs Administration (FDA) and the European Agency for Medicines (IEMA) is Epidiolex, but only for the therapeutic indication of a rather rare form of epilepsy, Lennox-Gastaut syndrome. Thus, it can be said that there are no registered cannabidiol-based pharmaceutical products for human medicine today except for a single, rare pathology!

 

Clinika M About

 

A galenic drug may, in turn, be officinal or magistral. An officinal galenic drug can be prepared by the pharmacist on the basis of an approved formulation and sold to patients who request it. A magistral galenic medicine, on the other hand, is prepared by the pharmacist, on the basis of specific instructions from the doctor, for an individual patient.

Cannabidiol, for medical purposes, can only be prescribed in Italy by doctors and prepared by pharmacists as a magistral galenic drug.

Magistral galenic preparations, based on CBD, are governed by the provisions of Italian Law No. 94 of April 1998, according to which doctors may prescribe magistral preparations exclusively based on active ingredients described in the pharmacopoeias of the countries of the European Union or contained in industrially produced medicinal products authorised for sale in Italy or in another country of the European Union.
With regard to CBD, reference is made to the German Pharmacopoeia of 2020 (DAB 2020 – Monograph Therapeutic Cannabis. Extract).

Professor Tullio Scrimali has created an original formulation, within the NegEnt project, for a magistral galenic cannabidiol preparation, according to an innovative and original recipe, which he wanted to make public, so that any doctor could adopt it for his own prescriptions and any galenic pharmacist could make it.

It is important to emphasise that the whole NegEnt project, devised and implemented by Professor Scrimali, is designed solely with the ethical aim of providing patients with a new cannabidiol preparation that is highly effective and free from side effects, and which can improve the treatment of many illnesses, which are still being treated with drugs that are difficult to handle and have many serious side effects, such as neuroleptics in psychiatry and non-steroidal and steroidal anti-inflammatory drugs in medicine.

  • Cannabidiol water soluble crystals GMP 2g
  • MCT oil 20%
  • Fruit aroma 3%
  • Sodium bicarbonate 0.7%
  • Stevia rebaudiana E.S. 98% Reb.A: 0.3%
  • Highly purified water, FU and emulsifier as needed to 30 ml

Fiat mixtura secundum artem: microemulsion for oral use

The patient takes 5 drops orally in the morning and 5 drops in the evening (for example). The drops should not be swallowed, but placed under the tongue and held for at least one minute! Absorption of CBD occurs through the oral mucosa. The prescription is not repeatable and is valid for 30 days. The reason for the prescription must be stated in the prescription, e.g. whether it is a supportive therapy to conventional therapies (clinical add-on approach), or whether as a stand-alone therapy it needs to be used because of the lack of an equivalent industrial drug

Professor Tullio Scrimali has successfully prescribed Magistral Galenic Cannabidiol, prepared according to the parameters of the ALETEIA Project to dozens of patients with many different clinical indications such as:

  • Schizophrenia
  • Neurocognitive Disorders (Dementias)
  • Feeding Disorders
  • Fibromyalgia
  • Ulcerative Rectocolitis
  • Degenerative Neuropathies
  • Multiple Sclerosis
  • Mild Cognitive Impairment due to ageing

The very positive scientific results achieved will soon be published in reputable international journals as single case studies.

However, the formulation and prescription of NegEnt, according to the formalities and provisions of the magisterial galenic drug, dictated by the so-called Di Bella Law, entail high costs for the patient, since, inevitably, the magisterial galenic preparation, as it is prepared, time by time, for single patients, entails high costs and, moreover, the prescription to be repeated every thirty days entails a commitment for doctors that, in the private setting, entails more costs for patients.

For these reasons, Professor Scrimali, with the sole ethical aim of making cannabidiol-based treatments cheaper and more accessible, has decided to develop NegEnt Aromaterapico which, formulated with the exact same characteristics as NegEnt, prepared instead as Magistral Galenic Cannabidiol, has a significantly lower cost and greater accessibility, as it can be prepared on a large scale and purchased without a prescription, through e-commerce which also provides, to save on shipping, pick-up at NegEnt Points of Herbal Neurocare.