The costs payable to Mylan should drive the final stake in this zombie….
This week’s agreement between POH, Mylan and Strides must have been a huge disappointment to those who’ve made it clear, in various ways, that they wish to see POH buried. And I don’t mean “they” in a singular, non-gender identifying way.
Forget about injectables….the Japanese are just researching out of curiosity imo .
If it is mere “curiosity” that has driven Terumo to develop and file a joint patent with POH for a TPM/propofol formulation, then Japanese “curiosity” is very curious indeed.
In POH’s August 2018 presentation, it was explained in the following slide how TPM can overcome some of the key challenges for injectable drugs.
According to the Terumo/POH joint patent for TPM/Propofol which was published this month, propofol as an injectable has the following key challenges
By incorporating TPM in a propofol formulation, the inventors have been able to eliminate the lipid components that make standard propofol formulation cloudy in appearance. Therefore, the TPM/Propofol formulation is less susceptible to bacterial and foreign material contamination and reduces the risk of patient allergy and hyperlipidemia. In addition, whereas standard propofol (Diprivan) must be used within 6 hours of dilution, the TPM/Propofol formulation is more stable at room temperature and can be used over 24 hours after dilution.
- propofol is hardly soluble in water due to its high lipid solubility
- therefore, propofol is generally administered in the form of an oil-in-water type emulsion containing lipid components such as soy bean oil, medium chain fatty acid triglyceride, or lecithin
- however, a preparation containing lipid components is prone to have bacterial proliferation
- also, the white cloudiness of a lipid emulsion means that contamination by foreign materials or bacteria cannot be determined based on an outer appearance so that a filter for removing them cannot be used
- furthermore, when a large amount of an emulsion containing lipid components is administered parenterally over a long period of time, there is a possibility that the patient may develop hyperlipidemia.
One advantage of improved dilution stability, as explained in the slide above, is the potential for multi-use formulations. Although this may seem an inconsequential benefit, it can be important in a time of drug shortage as explained in this article about injectable drug shortages which appeared in Fortune earlier this year.
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