Frequently asked questions

FAQ's

Answers to the most frequently asked questions about Senzer and its products.

What is THC or Tetrahydrocannabinol?

THC, or tetrahydrocannabinol, is a compound found in marijuana, and part of a group of compounds called cannabinoids. A synthetic form of THC, called Dronabinol, is approved by the U.S. Food and Drug Administration (FDA) and authorities in other countries as a prescription medicine. It is currently used by doctors as an appetite stimulant for the treatment of anorexia and as an antiemetic (a drug that treats nausea and vomiting) for vomiting and/or nausea caused by chemotherapy, a treatment for cancer. THC can be extracted directly from marijuana or, as in is the case with Dronabinol, synthesized from other sources.

What is CBD or Cannabidiol?

CBD, or Cannabidiol, is a cannabinoid compound found in marijuana. It does not have the psychoactive effects that THC does, and will not give any high feeling generally associated with consuming marijuana. A mixture of Cannabidiol and THC, known as Nabixamols, is approved in parts of Europe and a number of other countries as a medicine prescribed for the treatment of spasticity (muscle stiffness/spasm) caused by a disease called Multiple Sclerosis, or MS. CBD can be extracted directly from marijuana or synthesized from other sources.

What is Dronabinol?

Dronabinol is a synthetic form of tetrahydrocannabinol (THC), a common compound found in marijuana.

What is Nabilone?

Nabilone is a synthetic or man-made cannabinoid that mimics the effects of Tetrahydrocannabinol (THC). Nabilone is approved by some countries, including Canada and the UK as a prescription medicine used by doctors as an appetite stimulant for the treatment of anorexia and as an antiemetic to treat vomiting and/or nausea caused by chemotherapy, a treatment for cancer.

What is Systemic Medication?

Systemic medications are medicines that enter the bloodstream and travel throughout the body. These medicines have an effect on the entire body, as opposed to topical medicines, such as creams you put on a skin rash, that only have a local effect. Examples of ways to administer systemic medications include directly into the bloodstream through an injection into a vein (intravenous or IV) or absorbed through the intestinal tract when you swallow a pill. The SiDDTM inhaler is a new way to administer systemic medications that allows the medicine to quickly enter the bloodstream through the walls of the deep lung.

What is ISO13485 and why does it matter?

To ensure that the medicines and devices that pharmaceutical companies develop and manufacture are safe, reliable and effective, there are certain international standards they must comply with. There are standards for a range of different sectors and businesses, which are created by a global non-government organisation called International Organization for Standardization (ISO). The most important ISO standard for Senzer’s business is ISO13485 (Medical devices, Quality management systems (QMS), Requirements for regulatory purposes). This certification is essential for operating within the medical devices industry.

What is GMP?

Similar to ISO standards, Good Manufacturing Practices, or GMP, are the standards that a manufacturer must meet within their production processes. GMP guidance is created by regulatory agencies, like the FDA, that control authorization and licensing of medicines and drug products.

What's the difference between licensed and unlicensed medicine?

An unlicensed medicine, also known as a Special, is a medicine that has not been approved by the Government regulator for use in that country. Doctors are allowed to prescribe unlicensed medications on a patient-by-patient basis to meet the clinical needs of the individual if a suitable licensed medicine is not available. Licensed medications are medicines that have been authorised for normal distribution by the governing regulatory body within each country. In the U.K. this is the M.H.R.A. and in the U.S. it is the F.D.A. There are many different reasons as to why a licensed medicine may not be available. Usually, it’s because a licensed version of the formulation that would best meet the individual patient’s needs hasn’t been commercially produced. These Special prescriptions are dealt with in precisely the same way as a normal prescription, except that a pharmacist will have to make alternative arrangements to fulfil the prescription, either formulating it themselves or have it formulated by a pharmaceutical Specials manufacturer.

How is the SiDDTM different from a vape pen?

SiDDTM is a regulated pharmaceutical device that conforms to the same high standards as any other medicine. Vape pens are in most cases unregulated, so there is no way of knowing the quality of the vape pen or its contents. Unlike the vapour that comes out of a vape pen, medicine that is delivered through a regulated pharmaceutical device such as Senzer’s SiDDTM is tested for purity and to ensure that it’s free of any potential toxins and other harmful substances. Additionally, the SiDDTM uses a pressurised system and does not use a battery-powered heating element to generate a vapour, and is capable of deep lung absorption. As a result, there is no heat, smell or combustion.

Can I fill the SiDDTM with another medicinal canister (like my asthma canister)?

No, the SiDDTM refill canisters are specially designed for use with the design and technology used in the SiDDTM device.

Can the SiDDTM be used with other formulations or medicines?

Yes, the flexibility of the SiDDTM means that it has the potential to be used in the delivery of a wide range of medicines. Our in-house specialist formulation team is continuously looking for new and innovative ways the device and formulations can be used.