Welcome and first really comprehensive readable article I...

Welcome and first really comprehensive readable article I found.

I suppose potentially we can go direct to the Agila (now Mylan) patent where they have demonstrated in their own studies the effect of TPM being added as per below. Question then becomes whether the TPM Agila used is one and the same as POH or whether they managed to change or enhance it in some way? My simplistic thinking anyway, knowing it obviously isn't that simplistic unfortunately. 

Apols on formatting as on ph. 

https://patents.google.com/patent/EP3287138A1/en

Excerpt from patent showing by adding TPM to Dapto speeds up the reconstitution in time. 

Comparative reconstitution time for RLD vs. IH developed Generic 500 mg formulation vs. 500 mg TPM formulation (formulation of present invention)

Sr. No Strength Formulation Type Brand Name Reconstitution Time (with 10 mL of 0.9% Sodium chloride injection)

Procedure I Procedure II

With 10 min soaking procedure Direct swirling without soaking time of 10 min

Soaking time Reconstitution Time Total time

1 500 mg/ Vial RLD Cubicin 10 min 5 min 45 sec 15min 45 sec 9 min 51 sec

2 500 mg/Vial IH developed Generic Product NA 10 min 1 min 50 sec 11 min 50 sec 10 min 29 sec

3 500 mg/Vial IH developed TPM formulation NA NA NA NA 3 min 51sec

As well as. 

Unexpectedly, combining daptomycin with TPM showed enhanced chemical stability of daptomycin in reconstituted solution at different temperature conditions such as room temperature (25°C) and at 2-8°C. At room temperature, the reconstituted solution of the present invention was found to be stable for up to 24hours in contrast to the innovator product which needs to be used within 12 hours of reconstitution when stored at room temperature. Further, at 2 to 8°C the reconstituted solution of the present invention was found to be stable for up to 72 hours in contrast to the innovator product which needs to be used within 48 hours of reconstitution when stored at 2 to 8°C.

And the examiner also cited POH patent pre-dating Agilas (amongst others of course). 

WO2011094814A1 * 2010-02-05 2011-08-11 Phosphagenics Limited Carrier comprising non-neutralised tocopheryl phosphate