17. July 2018
By the advent of continuous pharmaceutical manufacturing, fast and accurate characterization of product quality has become of a major interest. Although it also promotes the real-time release testing approach, so far mainly content uniformity studies were performed by near-infrared (NIR) spectroscopy. This paper proposes the simultaneous application of NIR and Raman spectroscopy to nondestructively analyze the critical quality attributes of continuously produced tablets in a real-time release...
25. June 2018
The blending of powders is a critical step in pharmaceutical drug product manufacturing as it ensures that each dosage unit will contain the same intended fraction of active pharmaceutical ingredient (API). Under-blending thus poses a significant risk to patients where overdose or underdose can occur. Similarly, over-blending can lead to manufacturing issues such as reduced tablet tensile strengths as any included lubricants are dispersed further and further with additional blending. For these...
15. August 2017
Powder blend homogeneity is a critical attribute in formulation development of low dose and potent active pharmaceutical ingredients (API) yet a complex process with multiple contrib- uting factors.
21. June 2017
Powder blend homogeneity is a critical attribute in formulation development of low dose and potent active pharmaceutical ingredients (API) yet a complex process with multiple contributing factors. Excipient characteristics play key role in efficient blending process and final product quality. In this work the effect of excipient type and properties, blending technique and processing time on content uniformity was investigated.
16. June 2017
Powder blend homogeneity is a critical attribute in formulation development of low dose and potent active pharmaceutical ingredients (API) yet a complex process with multiple contributing factors. Excipient characteristics play key role in efficient blending process and final product quality.
15. June 2016
Context: The negative impact of magnesium stearate on the hardness of tablets is a well-known phenomenon, but the influence of paddle movement in the forced feeder on the lubricant effect during tablet compression is often neglected. Objective: The purpose of this research was to investigate the influence of paddle speed in the forced feeder on tablet tensile strength. Materials and methods: Mixtures of microcrystalline cellulose and magnesium stearate (0.5%) were blended using different...
15. March 2015
Polychromator-Type Near-Infrared Spectrometer with a High-speed and High-Resolution Photo Diode Array Detector Kodai Murayama 1,* , Daitaro Ishikawa 2,3,†, Takuma Genkawa 3,4,†, Hiroyuki Sugino 1, Makoto Komiyama 1 and Yukihiro Ozaki 3,* Received: 15 January 2015 / Revised: 17 February 2015 / Accepted: 26 February 2015 / Published: 3 March 2015 Abstract: In the present study we have developed a new version (ND-NIRs) of a polychromator-type near-infrared (NIR) spectrometer with a...