- just a reminder
16/9/20 from hottod
Avecho
The following information describing AVE’s TPM injectables products has been condensed from two presentations, which were released in December 2019 and June this year.
TPM®/Daptomycin
- Daptomycin is supplied as a lyophilized powder for reconstitution
- TPM increases daptomycin solubility, allowing reconstitution in < 5 minutes to significantly increase workflow efficiency in the hospital
- Daptomycin shelf-life stability increased to 24 hours at RT, and 72 hours in fridge.
- Longer stability also enables larger, multi-use vials and provides commercial supply chain advantage
TPM®/Propofol
- TPM creates a transparent and thermodynamically stable microemulsion
- No egg or soy based excipients, no risk of anaphylaxis, and reduced risk for bacterial growth
- Clear formulation (better presentation) allows QC and confidence during infusion / mixture – less chance of product recall
- Simple manufacture method; COGS projected to be cheaper than standard propofol emulsion
- TPM® would significantly reduce the risk and expense of the supply chain for propofol
- Could grow the overall propofol market, which has suffered from manufacturing issues and resulting product shortages
TPM®/Vitamin K
- TPM dissolves the Vitamin K in a stable, colloidal vesicle system
- TPM formulations of Vitamin K developed which are: - free of problematic excipients (Cremaphor, Polysorbate 80, Lecithin) - stable for 2yrs - suitable for dosing paediatric (2mg/ml) and adult (10mg/ml) patients
- There are no known allergens in the product, and no anticipated safety concerns.
TPM®/Tacrolimus
- TPM/Tacrolimus formulations made without Cremaphor (known adverse excipient)
- TPM solubilizes tacrolimus during dilution prior to infusion
TPM®/Melphalan
- Melpahan is a water insoluble powdered (lyophilized) drug dissolved prior to use
- There are no commercially available liquid formulations that would reduce handling prior to administration.
- Liquid TPM/melphalan formulations successfully created
TPM®/Clopidogrel
- Clopidogrel is a powder given as an oral tablet for stroke.
- An immediate, injectable alternative dosage format would be advantageous for stroke patients, but clopidogrel is insoluble at the typical pH range of IV injections (pH 3-10).
- Liquid TPM/clopidogrel formulations suitable for injection successfully created
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