Abstract
The aim of this work was to compare different brands of super-disintegrants (three brands of sodium starch glycolate and five brands of sodium croscarmellose) for their capability to interact with water either as loose powders or in tablets and to produce swelling force in tablets. Various batches of each brand were examined to check if the batch-to-batch variability could allow differentiation between various brands of the same product. The predictive power of measurements effected on powders with respect to disintegrant performance in model tablets, based on a sparingly soluble drug, was also investigated. As for the batch-to-batch variability of disintegrant powders, the five sodium croscarmellose brands showed a batch-to-batch variability higher than that observed for sodium starch glycolate samples: such a variability in some cases lead to the annihilation of the differences pointed out between the various brands. Similar considerations as for powders can be made with respect to the batch-to-batch variability of tablets. Only for sodium croscarmellose brands were the results of water penetration measurements effected on powders predictive of disintegrant efficiency in tablets, expressed by disintegration time.
| Original language | English |
|---|---|
| Pages (from-to) | 459-465 |
| Number of pages | 7 |
| Journal | S.T.P. Pharma Sciences |
| Volume | 10 |
| Issue number | 6 |
| Publication status | Published - 2000 |
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Keywords
- Batch-to-batch variability
- Brand-to-brand comparison
- Disintegrant functionality
- Hydration properties
- Sodium croscarmellose
- Sodium starch glycolate
- Swelling properties
ASJC Scopus subject areas
- Pharmaceutical Science
Cite this
The influence of product brand and batch-to-batch variability on super-disintegrant performance. / Ferrari, F.; Rossi, S.; Bonferoni, M. C.; Canevari, S.; Dobetti, L.; Caramella, C.
In: S.T.P. Pharma Sciences, Vol. 10, No. 6, 2000, p. 459-465.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - The influence of product brand and batch-to-batch variability on super-disintegrant performance
AU - Ferrari, F.
AU - Rossi, S.
AU - Bonferoni, M. C.
AU - Canevari, S.
AU - Dobetti, L.
AU - Caramella, C.
PY - 2000
Y1 - 2000
N2 - The aim of this work was to compare different brands of super-disintegrants (three brands of sodium starch glycolate and five brands of sodium croscarmellose) for their capability to interact with water either as loose powders or in tablets and to produce swelling force in tablets. Various batches of each brand were examined to check if the batch-to-batch variability could allow differentiation between various brands of the same product. The predictive power of measurements effected on powders with respect to disintegrant performance in model tablets, based on a sparingly soluble drug, was also investigated. As for the batch-to-batch variability of disintegrant powders, the five sodium croscarmellose brands showed a batch-to-batch variability higher than that observed for sodium starch glycolate samples: such a variability in some cases lead to the annihilation of the differences pointed out between the various brands. Similar considerations as for powders can be made with respect to the batch-to-batch variability of tablets. Only for sodium croscarmellose brands were the results of water penetration measurements effected on powders predictive of disintegrant efficiency in tablets, expressed by disintegration time.
AB - The aim of this work was to compare different brands of super-disintegrants (three brands of sodium starch glycolate and five brands of sodium croscarmellose) for their capability to interact with water either as loose powders or in tablets and to produce swelling force in tablets. Various batches of each brand were examined to check if the batch-to-batch variability could allow differentiation between various brands of the same product. The predictive power of measurements effected on powders with respect to disintegrant performance in model tablets, based on a sparingly soluble drug, was also investigated. As for the batch-to-batch variability of disintegrant powders, the five sodium croscarmellose brands showed a batch-to-batch variability higher than that observed for sodium starch glycolate samples: such a variability in some cases lead to the annihilation of the differences pointed out between the various brands. Similar considerations as for powders can be made with respect to the batch-to-batch variability of tablets. Only for sodium croscarmellose brands were the results of water penetration measurements effected on powders predictive of disintegrant efficiency in tablets, expressed by disintegration time.
KW - Batch-to-batch variability
KW - Brand-to-brand comparison
KW - Disintegrant functionality
KW - Hydration properties
KW - Sodium croscarmellose
KW - Sodium starch glycolate
KW - Swelling properties
UR - http://www.scopus.com/inward/record.url?scp=0034495456&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=0034495456&partnerID=8YFLogxK
M3 - Article
AN - SCOPUS:0034495456
VL - 10
SP - 459
EP - 465
JO - Journal of Drug Delivery Science and Technology
JF - Journal of Drug Delivery Science and Technology
SN - 1773-2247
IS - 6
ER -