Considerations for Successful Lyophilization Process Scale‐Up, Technology Transfer, and Routine Production

Sane, Samir U.; Hsu, Chia‐Wei

doi:10.1002/9780470595886.ch31

Cited by 7 publications

(3 citation statements)

References 14 publications

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“…Condenser continuously remove it. 35,36 At the end of MD the ice is mostly sublimed and the measured T ice decreases below the standard deviation of Tice during MD 37 . This effect can be used to change automatically from main to secondary drying (SD), e.g.…”

Section: Figure 3: the Collecting System Acts As A Cold Trap To Collectmentioning

confidence: 98%

Lyophilized Injection: A Modern Approach of Injectable Dosage Form

Sheena¹,

Parthiban²,

Selvakumar³

2018

J. Drug Delivery Ther.

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Now-a-days, lyophilized injection dosage form is extensively used to improve the bioavailability, stability, solubility and patient compliance. The lyophilized injection has considered as alternative to oral solid dosage forms for better patient compliance especially in bed ridden patients and for attaining maximum bioavailability, improved stability. The lyophilized injection reconstitute before injection to produce liquid injection. This review includes a detailed updated concept on lyophilized injection.

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Section: Figure 3: the Collecting System Acts As A Cold Trap To Collectmentioning

confidence: 98%

Lyophilized Injection: A Modern Approach of Injectable Dosage Form

Sheena¹,

Parthiban²,

Selvakumar³

2018

J. Drug Delivery Ther.

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“…Increasing the supercooling on nucleation results in a larger number of small crystals. It has been widely reported that the freezing profile and the nucleation temperature have a direct effect on the frozen microstructure and subsequent sublimation rate in a freeze drying process (Kochs et al 1991(Kochs et al , 1993Konstantinidis et al, 2011;Patel et al, 2009;Sane and Hsu, 2010;Searles et al, 2001).…”

Section: Model Of Sublimation Front Movementmentioning

confidence: 99%

A freeze-drying microscopy study of the kinetics of sublimation in a model lactose system

Rây

Rielly

Stapley

2017

Chemical Engineering Science

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Freeze drying microscopy has been used to probe the lyophilisation kinetics of lactose solutions of various concentrations, at temperatures ranging from -50°C to -30°C and under a constant pressure of 1 Pa. Sublimation front velocities were determined by recording a sequence of video images of the sublimation and analysing the frontal progression using MATLAB. Initial experiments showed poor reproducibility. To combat this, silver iodide (AgI) was added as an ice nucleator, which raised nucleation temperatures and improved reproducibility when compared to non-AgI experiments. The lower supercooling on nucleation when AgI was used also produced larger ice crystals, which enabled the crystal microstructure of the more dilute samples to be more clearly observed. This showed long thin crystals, and the orientation of these crystals with respect to the direction of the frontal movement strongly affected frontal progression rates, which explained the earlier reproducibility problems. A twin resistance mass transfer model, comprising a fixed edge resistance and a resistance which increased with frontal depth, was able to describe the sublimation kinetics. The edge resistance first increased and then decreased with solids content. The resistance per unit depth increased exponentially with solids content, so much so that there is an optimal solids content in relation to the rate of production of dried material.Resistances were also much higher when crystals were oriented with their major axis perpendicular to the direction of frontal movement. Freeze drying rates were approximately proportional to the saturation vapour pressure of water, however the long-held belief that water vapour pressure is the main driving force for mass transfer in freeze-drying systems may be an oversimplification as this only reflects driving forces in the vapour phase (pores) rather than within the solid.

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“…One can consider the "robust cycle" approach as an alternative to the trial-and-error strategy, where the cycle on the pilot scale with adequate safety margins is designed [17]. The parameters for the pilot scale need to be carefully determined considering the differences with the production scale equipment.…”

Section: Introductionmentioning

confidence: 99%

Best Practices and Guidelines (2022) for Scale-Up and Tech Transfer in Freeze-Drying Based on Case Studies. Part 1: Challenges during Scale Up and Transfer

et al. 2022

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The freeze-drying process scale-up and transfer remain a complicated and non-uniform practice. We summarized inefficient and good practices in these papers and provided some practical advice. It was demonstrated that using the same process set points/times in laboratory and commercial scale dryers may lead to loss of product quality (collapse or vial breakage). The emerging modeling approach demonstrated practical advantages. However, the upfront generation of some input parameters (vial heat transfer coefficient, minimum controllable pressure, and maximum sublimation rate) is essential for model utilization. While the primary drying step can be transferred with a high degree of confidence (e.g., using modeling), and secondary drying is usually fairly straightforward, predicting potential changes in product behavior during freezing remains challenging. Graphical Abstract

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Considerations for Successful Lyophilization Process Scale‐Up, Technology Transfer, and Routine Production

Cited by 7 publications

References 14 publications

Lyophilized Injection: A Modern Approach of Injectable Dosage Form

Lyophilized Injection: A Modern Approach of Injectable Dosage Form

A freeze-drying microscopy study of the kinetics of sublimation in a model lactose system

Best Practices and Guidelines (2022) for Scale-Up and Tech Transfer in Freeze-Drying Based on Case Studies. Part 1: Challenges during Scale Up and Transfer

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