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Delayed release film coating applications on oral solid dosage forms of proton pump inhibitors: case studies.
Drug Dev Ind Pharm. 2010 Feb; 36(2):180-9.DD

Abstract

BACKGROUND

Formulation of proton pump inhibitors (PPIs) into oral solid dosage forms is challenging because the drug molecules are acid-labile. The aim of this study is to evaluate different formulation strategies (monolithic and multiparticulates) for three PPI drugs, that is, rabeprazole sodium, lansoprazole, and esomeprazole magnesium, using delayed release film coating applications.

METHOD

The core tablets of rabeprazole sodium were prepared using organic wet granulation method. Multiparticulates of lansoprazole and esomeprazole magnesium were prepared through drug layering of sugar spheres, using powder layering and suspension layering methods, respectively. Tablets and drug-layered multiparticulates were seal-coated, followed by delayed release film coating application, using Acryl-EZE(R), aqueous acrylic enteric system. Multiparticulates were then filled into capsules. The final dosage forms were evaluated for physical properties, as well as in vitro dissolution testing in both compendial acid phase, 0.1N HCl (pH 1.2), and intermediate pH, acetate buffer (pH 4.5), followed by phosphate buffer, pH 6.8. The stability of the delayed release dosage forms was evaluated upon storage in accelerated conditions [40 degrees C/75% relative humidity] for 3 months.

RESULTS

All dosage forms demonstrated excellent enteric protection in the acid phase, followed by rapid release in their respective buffer media. Moreover, the delayed release dosage forms remained stable under accelerated stability conditions for 3 months.

CONCLUSIONS

Results showed that Acryl-EZE enteric coating systems provide excellent performance in both media (0.1N HCl and acetate buffer pH 4.5) for monolithic and multiparticulate dosage forms.

Authors+Show Affiliations

Colorcon, Inc., West Point, PA 19486, USA. smissaghi@colorcon.comNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article

Language

eng

PubMed ID

20070183

Citation

Missaghi, Shahrzad, et al. "Delayed Release Film Coating Applications On Oral Solid Dosage Forms of Proton Pump Inhibitors: Case Studies." Drug Development and Industrial Pharmacy, vol. 36, no. 2, 2010, pp. 180-9.
Missaghi S, Young C, Fegely K, et al. Delayed release film coating applications on oral solid dosage forms of proton pump inhibitors: case studies. Drug Dev Ind Pharm. 2010;36(2):180-9.
Missaghi, S., Young, C., Fegely, K., & Rajabi-Siahboomi, A. R. (2010). Delayed release film coating applications on oral solid dosage forms of proton pump inhibitors: case studies. Drug Development and Industrial Pharmacy, 36(2), 180-9. https://doi.org/10.3109/03639040903468811
Missaghi S, et al. Delayed Release Film Coating Applications On Oral Solid Dosage Forms of Proton Pump Inhibitors: Case Studies. Drug Dev Ind Pharm. 2010;36(2):180-9. PubMed PMID: 20070183.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Delayed release film coating applications on oral solid dosage forms of proton pump inhibitors: case studies. AU - Missaghi,Shahrzad, AU - Young,Cara, AU - Fegely,Kurt, AU - Rajabi-Siahboomi,Ali R, PY - 2010/1/15/entrez PY - 2010/1/15/pubmed PY - 2010/3/24/medline SP - 180 EP - 9 JF - Drug development and industrial pharmacy JO - Drug Dev Ind Pharm VL - 36 IS - 2 N2 - BACKGROUND: Formulation of proton pump inhibitors (PPIs) into oral solid dosage forms is challenging because the drug molecules are acid-labile. The aim of this study is to evaluate different formulation strategies (monolithic and multiparticulates) for three PPI drugs, that is, rabeprazole sodium, lansoprazole, and esomeprazole magnesium, using delayed release film coating applications. METHOD: The core tablets of rabeprazole sodium were prepared using organic wet granulation method. Multiparticulates of lansoprazole and esomeprazole magnesium were prepared through drug layering of sugar spheres, using powder layering and suspension layering methods, respectively. Tablets and drug-layered multiparticulates were seal-coated, followed by delayed release film coating application, using Acryl-EZE(R), aqueous acrylic enteric system. Multiparticulates were then filled into capsules. The final dosage forms were evaluated for physical properties, as well as in vitro dissolution testing in both compendial acid phase, 0.1N HCl (pH 1.2), and intermediate pH, acetate buffer (pH 4.5), followed by phosphate buffer, pH 6.8. The stability of the delayed release dosage forms was evaluated upon storage in accelerated conditions [40 degrees C/75% relative humidity] for 3 months. RESULTS: All dosage forms demonstrated excellent enteric protection in the acid phase, followed by rapid release in their respective buffer media. Moreover, the delayed release dosage forms remained stable under accelerated stability conditions for 3 months. CONCLUSIONS: Results showed that Acryl-EZE enteric coating systems provide excellent performance in both media (0.1N HCl and acetate buffer pH 4.5) for monolithic and multiparticulate dosage forms. SN - 1520-5762 UR - https://www.unboundmedicine.com/medline/citation/20070183/Delayed_release_film_coating_applications_on_oral_solid_dosage_forms_of_proton_pump_inhibitors:_case_studies_ DB - PRIME DP - Unbound Medicine ER -