| Title |
Application of QbD Principles for the Evaluation of Empty Hard Capsules as an Input Parameter in Formulation Development and Manufacturing
|
|---|---|
| Published in |
AAPS PharmSciTech, February 2014
|
| DOI | 10.1208/s12249-014-0094-y |
| Pubmed ID | |
| Authors |
Sven Stegemann, Paul Connolly, Wayne Matthews, Rodger Barnett, Mike Aylott, Karin Schrooten, Dominique Cadé, Anthony Taylor, Massimo Bresciani |
| Abstract |
Understanding the product and process variable on the final product performance is an essential part of the quality-by-design (QbD) principles in pharmaceutical development. The hard capsule is an established pharmaceutical dosage form used worldwide in development and manufacturing. The empty hard capsules are supplied as an excipient that is filled by pharmaceutical manufacturers with a variety of different formulations and products. To understand the potential variations of the empty hard capsules as an input parameter and its potential impact on the finished product quality, a study was performed investigating the critical quality parameters within and in between different batches of empty hard gelatin capsules. The variability of the hard capsules showed high consistency within the specification of the critical quality parameters. This also accounts for the disintegration times, when automatic endpoint detection was used. Based on these data, hard capsules can be considered as a suitable excipient for product development using QbD principles. |
X Demographics
The data shown below were collected from the profile of 1 X user who shared this research output. Click here to find out more about how the information was compiled.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 1 | 100% |
Demographic breakdown
| Type | Count | As % |
|---|---|---|
| Science communicators (journalists, bloggers, editors) | 1 | 100% |
Mendeley readers
The data shown below were compiled from readership statistics for 51 Mendeley readers of this research output. Click here to see the associated Mendeley record.
Geographical breakdown
| Country | Count | As % |
|---|---|---|
| Unknown | 51 | 100% |
Demographic breakdown
| Readers by professional status | Count | As % |
|---|---|---|
| Researcher | 11 | 22% |
| Student > Master | 6 | 12% |
| Other | 5 | 10% |
| Student > Ph. D. Student | 3 | 6% |
| Student > Postgraduate | 2 | 4% |
| Other | 3 | 6% |
| Unknown | 21 | 41% |
| Readers by discipline | Count | As % |
|---|---|---|
| Pharmacology, Toxicology and Pharmaceutical Science | 17 | 33% |
| Agricultural and Biological Sciences | 4 | 8% |
| Chemistry | 3 | 6% |
| Medicine and Dentistry | 2 | 4% |
| Energy | 1 | 2% |
| Other | 2 | 4% |
| Unknown | 22 | 43% |
Attention Score in Context
This research output has an Altmetric Attention Score of 1. This is our high-level measure of the quality and quantity of online attention that it has received. This Attention Score, as well as the ranking and number of research outputs shown below, was calculated when the research output was last mentioned on 14 February 2014.
All research outputs
#15,293,290
of 22,743,667 outputs
Outputs from AAPS PharmSciTech
#1,065
of 1,469 outputs
Outputs of similar age
#193,604
of 314,263 outputs
Outputs of similar age from AAPS PharmSciTech
#28
of 32 outputs
Altmetric has tracked 22,743,667 research outputs across all sources so far. This one is in the 22nd percentile – i.e., 22% of other outputs scored the same or lower than it.
So far Altmetric has tracked 1,469 research outputs from this source. They receive a mean Attention Score of 4.0. This one is in the 20th percentile – i.e., 20% of its peers scored the same or lower than it.
Older research outputs will score higher simply because they've had more time to accumulate mentions. To account for age we can compare this Altmetric Attention Score to the 314,263 tracked outputs that were published within six weeks on either side of this one in any source. This one is in the 28th percentile – i.e., 28% of its contemporaries scored the same or lower than it.
We're also able to compare this research output to 32 others from the same source and published within six weeks on either side of this one. This one is in the 12th percentile – i.e., 12% of its contemporaries scored the same or lower than it.