1,2) Until recently, the identification of an appropriate excipient
has relied on a trial-and-error-based methodology.
M2 PHARMA-May 2, 2017-ReForm Biologics Issued US Patent for New Excipient
to Improve Antibody-Based Therapeutics
The mixtures of active ingredient and excipient
were made according to the 18-run D-optimal mixture design.
Development of highly soluble excipients
for sustained and controlled release formulations, global pharmaceutical excipient
outsourcing, manufacturing of co-processed excipients
using nano- and liposome-mediated technologies, strategic partnership/alliance among excipient
manufacturers are some of the factors driving pharmaceutical excipient
market whereas less interest in developing novel excipients
, contamination issues in formulations, and delay in approval of novel excipients
are the factors restraining market growth.
The new company, which will be led by Kayon Partners principals Stephen Garrow and David Vogel, will work with the UMASS tech transfer team and with established companies in the food and drug industries, to custom-develop excipient
foods, which can be used along with a variety of drugs and vitamins.
products such as sugar are also expected to witness robust growth over the forecast period.
In this study, DMA was cured into a silicone matrix at 5%, 10% and 15% concentrations (m/m) along with varying concentrations of excipient
A (0-20%) or excipient
B (0-12%), The silicone sample was placed in a simulated physiological environment and HPLC analysis was conducted daily on the eluent, allowing quantification of drug release into the physiological solution on a daily basis over 14 days.
Product versatility will be a key factor impacting product mix in excipient
demand going forward, especially as specialty excipient
blends play an increasingly important role in pharmaceutical formulation.
The authors report that labeling information for 6 RX drug products included di-n-butyl phthalate (DBF) as an excipient
and 45 labels specified diethyl phthalate (DEP).
1) In his statement, Carter notes: "IPEC'S proposal would mandate that individuals or companies not be allowed to import into the US a drug or excipient
used in the manufacture of a drug if the product or ingredient was manufactured or produced outside the US by an entity which has not been certified by FDA or an FDA-recognized third-party auditor.
For a new excipient
to be accepted by regulatory authorities, it must undergo the required demonstration studies on chronic and acute toxicity, pharmacokinetics, toxicology and reproductive effects.
For compatibility screening, 3 different methods were used to prepare drug excipient
binary mixtures, namely physical admixing with 5% moisture, kneading and slugging.