Application of a handheld NIR spectrometer in prediction of drug content in inkjet printed orodispersible formulations

[helvella]

A new chapter of medicine delivery is approaching. Would like to know very much more detail - and we might get to know more as further research is published. What would be the real push towards printed levothyroxine?

Can you imagine getting a prescription that doesn't need to be dispensed? You just tear off bits of the actual prescription...

Int J Pharm. 2017 Apr 7. pii: S0378-5173(17)30295-8. doi: 10.1016/j.ijpharm.2017.04.014. [Epub ahead of print]

Application of a handheld NIR spectrometer in prediction of drug content in inkjet printed orodispersible formulations containing prednisolone and levothyroxine.

Vakili H1, Wickström H2, Desai D2, Preis M2, Sandler N2.

Author information

1 Pharmaceutical Sciences Laboratory, Åbo Akademi University, Tykistökatu 6A, FI-20540, Turku, Finland. Electronic address: [e-mail].

2 Pharmaceutical Sciences Laboratory, Åbo Akademi University, Tykistökatu 6A, FI-20540, Turku, Finland.

Abstract

Quality control tools to assess the quality of printable orodispersible formulations are yet to be defined. Four different orodispersible dosage forms containing two poorly soluble drugs, levothyroxine and prednisolone, were produced on two different edible substrates by piezoelectric inkjet printing. Square shaped units of 4cm2 were printed in different resolutions to achieve an escalating drug dose by highly accurate and uniform displacement of droplets in picoliter range from the printhead onto the substrates. In addition, the stability of drug inks in a course of 24h as well as the mechanical properties and disintegration behavior of the printed units were examined. A compact handheld near-infrared (NIR) spectral device in the range of 1550-1950nm was used for quantitative estimation of the drug amount in printed formulations. The spectral data was treated with mean centering, Savitzky-Golay filtering and a third derivative approach. Principal component analysis (PCA) and orthogonal partial least squares (OPLS) regression were applied to build predictive models for quality control of the printed dosage forms. The accurate tuning of the dose in each formulation was confirmed UV spectrophotometry for prednisolone (0.43-1.95mg with R2=0.999) and high performance liquid chromatography for levothyroxine (0.15-0.86mg with R2=0.997). It was verified that the models were capable of clustering and predicting the drug dose in the formulations with both Q2 and R2Y values between 0.94-0.99.

Copyright © 2017. Published by Elsevier B.V.

KEYWORDS:

Dimethyl sulfoxide (PubChem CID: 24893977); Glycerol (PubChem CID: 753); Hydrochloric acid (PubChem CID: 313); Hydroxypropyl cellulose (PubChem CID: 123706); Hydroxypropyl methylcellulose (PubChem CID: 57503849); Levothyroxine sodium salt pentahydrate (PubChem CID: 24900041); Methanol (PubChem CID: 887); NIR spectroscopy; Potassium dihydrogen phosphate (PubChem CID: 516951); Prednisolone (PubChem CID: 24898725); Propylene glycol (PubChem CID: 24901410); Sodium hydroxide (PubChem CID: 14798); multivariate analysis; orodispersible formulations; personalized medicine; piezoelectric inkjet printing; quality control

PMID: 28396245

DOI: 10.1016/j.ijpharm.2017.04.014

ncbi.nlm.nih.gov/pubmed/?cm...

A tiny bit more available here:

sciencedirect.com/science/a...

[greygoose]

Oh, you'd never get that in France! The pharmacists would see it as a threat to their supremacy. They'd be out in the streets waving banners 'make them come to the pharmacy for their edible prescriptions!' and 'no dosing without our nosing!' - they like to know all the sordid details of your diagnosis. And, of course, there's always the hope that you'll buy a bottle of cologne, or a bar of soap, on your way out. Pft.

[helvella Administrator in reply to greygoose]

Opens the way for Michelin rosettes for medicines?

[greygoose in reply to helvella]

Bof