Influence of the mesh of extrusion dies on the properties of cores intended for the preparation of pellets with controlled glucose release

Authors: Sylvie Pavloková;  Aleš Franc;  Jan Muselík;  Dana Sabadková;  Pavlína Kopecká;  David Neumann
Authors‘ workplace: Ústav technologie léků, Farmaceutická fakulta Veterinární a farmaceutická univerzita ;  Dětská klinika 1. LF UK a FN, Hradec Králové, Česká republika 2
Published in: Čes. slov. Farm., 2016; 65, 22-27
Category: Original Articles


Diabetes mellitus and its compensation are accompanied by serious complications. One of them is hypoglycaemia, which occurs in patients treated with insulin and/or certain peroral antidiabetics. Hypoglycaemic episodes can be prevented by a dosage form with controlled release of glucose. The pellet cores of four compositions and three different sizes corresponding to the diameter of extrusion screen mesh (0.6, 0.8, and 1.0 mm) were prepared for this purpose. The cores contain 75–80% of glucose combined with one of the following osmotically or swellable active agents: croscarmellose sodium (ADS), a mixture of microcrystalline cellulose and carmellose sodium Avicel RC 591 (RC), polyethylene glycol 6000 (PEG), and carboxymethyl starch (CMS). The cores were prepared by extrusion-spheronization and are intended for subsequent coating by a semipermeable membrane based on ethylcellulose. The aim of the work was to statistically evaluate the results of the physical evaluation of the pellets which were prepared and evaluated in previously published papers. The results are processed in the form of a meta-analysis using principle component analysis. The physical characteristics of the individual pellet sizes were different among themselves. Although the same compositions and manufacturing methods were used for all the pellets sizes, the cores produced through a 0.6 and 0.8 mm mesh screens showed similar properties while the properties of cores produced through a 1.0 mm mesh screen were rather different.

Key words:
hypoglycemiadelayed releaseglucoseprincipal component analysis PCAmeta-analysis of data


1. American Diabetes Association Workgroup on Hypoglycaemia. 2005.

2. Fisher M., Heller S. R. Hypoglycaemia in clinical diabetes. 2nd ed. Chichester, UK: John Wiley & Sons 1999.

3. Fanelli C. G., Porcellati F., Pampenelli S., Bolli G. B. Insulin therapy and hypoglycaemia: the size of the problem. Diabetes Metab. Res. Rev. 2004; 20(2), 32–42.

4. Ryan C., Gurtunca N., Becker D. Hypoglycemia: a complication of diabetes therapy in children. Pediatr. Clin. North Am. 2005; 52, 1705–1733.

5. Franc A., Dvořáčková K., Muselík J., Žvaková M., Slováková V., Vetchý D., Sabadková D., Neumann D., Goněc R.  Formulation of cores for the controlled release of glucose for prevention of hypoglycemia in diabetes patients. Čes. slov. Farm. 2014; 63, 206–212.

6. Heng P. W., Chan L. W., Chew S. H. Mechanism of pellet coat rupture and its effect on drug release. Chem. Pharm. Bull. 1999; 47(7), 939–943.

7. Sabadková D., Franc A., Muselík J., Neumann D. Coated pellets based on delayed release glucose as prevention of hypoglycemic episodes. Acta Pharmaceut. 2016 (v tisku).

8. Franc A., Muselík J., Sabadková D., Neumann D. Preparation of pellets with controlled release of glucose as prevention of hypoglycaemia in paediatric patients. Eur. J. Pharm. Sci. 2015; 75, 72–80.

9. R Core Team. R: A language and environment for statistical computing. R Foundation for Statistical Computing, Vienna, Austria. 2015.

10. Franc A., Sabadková D., Neumann D., Pavloková S., Kopecká P., Muselík J. Interdiction of hypoglycemia in diabetic children by multiparticulate dosage form with controlled glucose release. Pharm. Dev. Technol. 2015; 1–8.

11. Council of Europe. European Pharmacopoeia, 8th edition. Council of Europe, Strasbourg 2013.

12. Rabišková M. Technologické parametry lékových mikroforem, jejich význam a metody jejich stanovení. Čes. slov. Farm. 1996; 45, 177–179.

13. Rabišková M., Masteiková R., Chalupová Z., Dvořáčková K. Lékové formy a biofarmacie: II. Brno: Veterinární a farmaceutická univerzita 2009.

14. Podczeck F., Rahman S. R., Newton J. M. Evaluation of a standardised procedure to assess the shape of pellets using image analysis. Int. J. Pharm. 1999; 192, 123–138.

15. Chopra R. F., Podczeck J. M., Alderborn G. The influence of pellet shape and film coating on the filling of pellets into hard shell capsules. Eur. J. Pharm. Biopharm. 2002; 53, 327–333.

16. Rhodes C. T., Porter S. C. Coatings for controlled-release drug delivery systems. Drug. Dev. Ind. Pharm. 1998; 24, 1139–1154.

17. Saary M. Joan. Radar plots: a useful way for presenting multivariate health care data. J. Clin. Epidemiol. 2008; 61(4), 311–317.

18. Wehrens, R. Chemometrics with R. 1st ed. Heidelberg: Springer 2011.

Pharmacy Clinical pharmacology
Forgotten password

Don‘t have an account?  Create new account

Forgotten password

Enter the email address that you registered with. We will send you instructions on how to set a new password.


Don‘t have an account?  Create new account