Carboxymethyl high amylose starch as excipient for controlled drug release: Mechanistic study and the influence of degree of substitution

International Journal of Pharmaceutics

Volumn 382, Issue 1-2, 2009, Pages 172-182

  Lemieux, Marc ^a   Gosselin, Patrick ^b   Mateescu, Mircea Alexandru ^a  

^a UNIVERSITÉ DU QUÉBEC À MONTRÉAL   (Canada)

^b INSTITUTE FOR RESEARCH IN IMMUNOLOGY AND CANCER   (Canada)

Author keywords

Carboxymethyl high amylose starch; Degree of substitution; Delayed delivery; Monolithic tablet; Non aqueous synthesis; Sustained release

Indexed keywords

AMYLOSE; CARBOXYMETHYLSTARCH SODIUM; PARACETAMOL;

ARTICLE; CONTROLLED DRUG RELEASE; CONTROLLED STUDY; DIFFUSION; DRUG SOLUBILITY; HYDROPHILICITY; IN VITRO STUDY; INTESTINE FLUID; PH; PRIORITY JOURNAL; SIMULATION; STOMACH JUICE; SUBSTITUTION REACTION; SUSTAINED RELEASE PREPARATION; TABLET FORMULATION;

ACETAMINOPHEN; AMYLOSE; CHEMISTRY, PHARMACEUTICAL; DELAYED-ACTION PREPARATIONS; DIFFUSION; DRUG CARRIERS; DRUG COMPOUNDING; EXCIPIENTS; GASTRIC JUICE; HYDROGEN-ION CONCENTRATION; INTESTINAL SECRETIONS; KINETICS; PARTICLE SIZE; SOLUBILITY; SURFACE PROPERTIES; TABLETS; WATER;

EID: 70350324894     PISSN: 03785173     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.ijpharm.2009.08.030     Document Type: Article

References (46)

1. Adolfsson A., Olsson H., and Nyström C. Effect of particle size and compaction load on interparticulate bonding structure for some pharmaceutical materials studied by compaction and strength characterisation in butanol. Eur. J. Pharm. Biopharm. 44 (1997) 243-251
2. Amidon G.E., and Houghton M.E. The effect of moisture on the mechanical and powder flow properties of microcrystalline cellulose. Pharm. Res. 12 (1995) 923-929
3. Calinescu C., Mulhbacher J., Nadeau E., Fairbrother J.M., and Mateescu M.A. Carboxymethyl high amylose starch (CM-HAS) as excipient for Escherichia coli oral formulations. Eur. J. Pharm. Biopharm. 60 (2005) 53-60
4. Calinescu C., Nadeau E., Mulhbacher J., Fairbrother J.M., and Mateescu M.A. Carboxymethyl high amylose starch for F4 fimbriae gastro-resistant oral formulation. Int. J. Pharm. 343 (2007) 18-25
5. Carr R.L. Classifying flow properties of solids. Chem. Eng. 72 (1965) 69-72
6. Chen J., and Jane J. Preparation of granular cold-water-soluble starches by alcoholic-alkaline treatment. Cereal Chem. 71 (1994) 618-622
7. Chen J., and Jane J. Properties of granular cold-water-soluble starches prepared by alcoholic-alkaline treatments. Cereal Chem. 71 (1994) 623-626
8. Colombo P., Bettini R., Catellani P.L., Santi P., and Peppas N.A. Drug volume fraction profile in the gel phase and drug release kinetics in hydroxypropylmethyl cellulose matrices containing a soluble drug. Eur. J. Pharm. Sci. 9 (1999) 33-40
9. Colombo P., Bettini R., Santi P., and Peppas N.A. Swellable matrices for controlled drug delivery: gel-layer behaviour, mechanisms and optimal performance. Pharm. Sci. Technol. Today 3 (2000) 198-204
10. Demirgoz D., Elvira C., Mano J.F., Cunha A.M., Piskin E., and Reis R.L. Chemical modification of starch based biodegradable polymeric blends: effects on water uptake, degradation behaviour and mechanical properties. Polym. Degrad. Stab. 70 (2000) 161-170
11. Désévaux C., Dubreuil P., Lenaerts V., and Girard C. Tissue reaction and biodegradation of implanted cross-linked high amylose starch in rats. J. Biomed. Mater. Res. 63 (2002) 772-779
12. Dumoulin Y., Cartilier L.H., and Mateescu M.A. Cross-linked amylose tablets containing α-amylase: an enzymatically-controlled drug release system. J. Control. Release 60 (1999) 161-167
13. Gupta A., Peck G.E., Miller R.W., and Morris K.R. Influence of ambient moisture on the compaction behavior of microcrystalline cellulose powder undergoing uni-axial compression and roller-compaction: a comparative study using near-infrared spectroscopy. J. Pharm. Sci. 94 (2005) 2301-2313
14. Hausner H.H. Friction conditions in a mass of metal powders. Int. J. Powder Metall. 3 (1967) 7-13
15. Heinze T., and Koschella A. Carboxymethyl ethers of cellulose and starch-a review. Macromol. Symp. 223 (2005) 13-40
16. Heinze T., Liebert T., Heinze U., and Schwikal K. Starch derivatives of high degree of functionalization 9: carboxymethyl starches. Cellulose 11 (2004) 239-245
17. Ispas-Szabo P., De Koninck P., Calinescu C., and Mateescu M.A. Novel carboxymethyl starch excipients for oral dosage forms. Proceedings of the 34th Annual Meeting and Exposition of the Controlled Release Society. Controlled Release Society (CRS), Long Beach, California (2007)
18. Khare A.R., and Peppas N.A. Swelling/deswelling of anionic copolymer gels. Biomaterials 16 (1995) 559-567
19. Kooijman L.M., Ganzeveld K.J., Manurung R.M., and Heeres H.J. Experimental studies on the carboxymethylation of arrowroot starch in isopropanol-water media. Starch-Stärke 55 (2003) 495-503
20. Korhonen O., Pohja S., Peltonen S., Suihko E., Vidgren M., Paronen P., and Ketolainen J. Effects of physical properties for starch acetate powders on tableting. AAPS PharmSciTech 3 (2002) 1-9
21. Korhonen O., Raatikainen P., Harjunen P., Nakari J., Suihko E., Peltonen S., Vidgren M., and Paronen P. Starch acetates-multifunctional direct compression excipients. Pharm. Res. 17 (2000) 1138-1143
22. Kost J., and Shefer S. Chemically-modified polysaccharides for enzymatically-controlled oral drug delivery. Biomaterials 11 (1990) 695-698
23. Kwon K., Auh J.H., Kim J.-W., Park K.H., Park C.H., and Ko C.J. Physicochemical properties and functionality of highly carboxymethylated starch. Starch-Stärke 49 (1997) 499-505
24. Lazik W., Heinze T., Pfeiffer K., Albrecht G., and Mischnick P. Starch derivatives of a high degree of functionalization. VI. Multistep carboxymethylation. J. Appl. Polym. Sci. 86 (2002) 743-752
25. Lemieux M., Gosselin P., and Mateescu M.A. Influence of drying method of carboxymethyl high amylose starch (CM-HAS) derivatives on physical properties and drug release profiles. 2007 AAPS Annual Meeting and Exposition. San Diego Convention Center, San Diego, CA, USA (2007)
26. Lenaerts V., Dumoulin Y., and Mateescu A.M. Controlled release of theophylline from cross-linked amylose tablets. J. Control. Release 15 (1991) 39-46
27. Mulhbacher J., Ispas-Szabo P., and Mateescu M.A. Cross-linked high amylose starch derivatives for drug release. II. Swelling properties and mechanistic study. Int. J. Pharm. 278 (2004) 231-238
28. Mulhbacher, J., Mateescu, M.A., Calinescu, C., 2008. Composition comprising polymeric material and uses thereof. US Patent Application 20,080,286,253, July 17.
29. Nabais T., Brouillet F., Kyriacos S., Mroueh M., Amores da Silva P., Bataille B., Chebli C., and Cartilier L. High-amylose carboxymethyl starch matrices for oral sustained drug-release: in vitro and in vivo evaluation. Eur. J. Pharm. Biopharm. 65 (2007) 371-378
30. Nystrom C., and Karehill P.-G. The importance of intermolecular bouding forces and the concept of bounding surface area. In: Aldernborn G., and Nyström C. (Eds). Pharmaceutical Powder Compaction Technology vol. 71 (1996), Marcel Dekker Inc., New York 17-54
31. Peppas N.A., and Sahlin J.J. A simple equation for the description of solute release. III. Coupling of diffusion and relaxation. Int. J. Pharm. 57 (1989) 169-172
32. Pifferi G., Santoro P., and Pedrani M. Quality and functionality of excipients. Farmaco 54 (1999) 1-14
33. Rowe R.C., Sheskey P.J., and Owen S.C. Handbook of Pharmaceutical Excipients. 5th ed. (2006), Pharmaceutical Press, London
34. Sangseethong K., Ketsilp S., and Sriroth K. The role of reaction parameters on the preparation and properties of carboxymethyl cassava starch. Starch-Stärke 57 (2005) 84-93
35. Sarko A., and Wu H.-C.H. The crystal structures of A-, B- and C-polymorphs of amylose and starch. Starch-Stärke 30 (1978) 73-78
36. Stella V.J., and Rajewski R.A. Cyclodextrins: their future in drug formulation and delivery. Pharm. Res. 14 (1997) 556-567
37. Stojanovic Z., Jeremic K., and Jovanovic S. Synthesis of carboxymethyl starch. Starch-Stärke 52 (2000) 413-419
38. Stojanovic Z., Jeremic K., Jovanovic S., and Lechner M.D. A comparison of some methods for the determination of the degree of substitution of carboxymethyl starch. Starch-Stärke 57 (2005) 79-83
39. Sun C.C. Mechanism of moisture induced variations in true density and compaction properties of microcrystalline cellulose. Int. J. Pharm. 346 (2008) 93-101
40. Takahashi H., Chen R., Okamoto H., and Danjo K. Acetaminophen particle design using chitosan and a spray-drying technique. Chem. Pharm. Bull. 53 (2005) 37-41
41. Te Wierik G.H.P., Eissens A.C., Bergsma J., Arends-Scholte A.W., and Lerk C.F. A new generation of starch products as excipient in pharmaceutical tablets. II. High surface area retrograded pregelatinized potato starch products in sustained-release tablets. J. Control. Release 45 (1997) 25-33
42. Tijsen C.J., Kolk H.J., Stamhuis E.J., and Beenackers A.A.C.M. An experimental study on the carboxymethylation of granular potato starch in non-aqueous media. Carbohydr. Polym. 45 (2001) 219-226
43. Tijsen C.J., Scherpenkate H.J., Stamhuis E.J., and Beenackers A.A.C.M. Optimisation of the process conditions for the modification of starch. Chem. Eng. Sci. 54 (1999) 2765-2772
44. US Pharmacopeia XXXI, 2008. US Pharmacopeial Convention. Rockville, MD.
45. Volkert B., Loth F., Lazik W., and Engelhardt J. Highly substituted carboxymethyl starch. Starch-Stärke 56 (2004) 307-314
46. Wurzburg O.B. Introduction. In: Wurzburg O.B. (Ed). Modified Starches: Properties and Uses vol. 1 (1986), CRC Press, Boca Raton 4-15