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Compounding of vitamin A, D3, E and K3 supplements for cystic fibrosis patients: formulation and stability study.
J Clin Pharm Ther. 2007 Oct; 32(5):489-96.JC

Abstract

BACKGROUND AND OBJECTIVE

Cystic fibrosis (CF) patients suffer from malabsorption of fat-soluble vitamins (A, D, E and K). These vitamins are available as water-dispersible (A, D(3) and E) or water-soluble grades (K(3)), which is favoured in CF patients as they fail to absorb oil-based products. The objective of this study was to determine stability of these raw materials after opening the original package and to develop a compounded formulation of acceptable quality, stability and taste, allowing flexible dose adaptation and being appropriate for administration to children and elderly people.

METHODS

The raw materials were stored after opening their original package for 8 months at 8 degrees C and room temperature (RT). Stability was assessed using a validated HPLC method after extraction of the vitamin from the cold water-soluble matrix (vitamin A acetate, D(3) and E) or using a spectrophotometrical method (vitamin K(3)). These materials were mixed with an appropriate lactose grade (lactose 80 m for vitamins A and D(3); lactose 90 m for vitamin E, lactose very fine powder for vitamin K(3)) and filled in hard gelatin capsules. Mass and content uniformity were determined and stability of the vitamins in the capsules was assessed after 2 months storage at 8 degrees C and RT.

RESULTS

All raw materials showed good stability during storage in the opened original package for 8 months storage at 8 degrees C as well as RT (>95% of the initial content). The compounded formulations complied with the requirements of the European Pharmacopoeia for mass and content uniformity and can be stored for 2 months at 8 degrees C or RT while maintaining the vitamin content between 90% and 110%.

CONCLUSIONS

As these fat-soluble vitamins are not commercially available on the Belgian market, compounded formulations are a valuable alternative for prophylactic administration of these vitamins to CF patients, i.e. a stable formulation, having an acceptable taste, allowing flexible dose adaptation and being appropriate for administration to children and elderly people.

Authors+Show Affiliations

Laboratory of Pharmaceutical Technology, Ghent University, Gent, Belgium.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

17875116

Citation

Huyghebaert, N, et al. "Compounding of Vitamin A, D3, E and K3 Supplements for Cystic Fibrosis Patients: Formulation and Stability Study." Journal of Clinical Pharmacy and Therapeutics, vol. 32, no. 5, 2007, pp. 489-96.
Huyghebaert N, De Beer J, Vervaet C, et al. Compounding of vitamin A, D3, E and K3 supplements for cystic fibrosis patients: formulation and stability study. J Clin Pharm Ther. 2007;32(5):489-96.
Huyghebaert, N., De Beer, J., Vervaet, C., & Remon, J. P. (2007). Compounding of vitamin A, D3, E and K3 supplements for cystic fibrosis patients: formulation and stability study. Journal of Clinical Pharmacy and Therapeutics, 32(5), 489-96.
Huyghebaert N, et al. Compounding of Vitamin A, D3, E and K3 Supplements for Cystic Fibrosis Patients: Formulation and Stability Study. J Clin Pharm Ther. 2007;32(5):489-96. PubMed PMID: 17875116.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Compounding of vitamin A, D3, E and K3 supplements for cystic fibrosis patients: formulation and stability study. AU - Huyghebaert,N, AU - De Beer,J, AU - Vervaet,C, AU - Remon,J P, PY - 2007/9/19/pubmed PY - 2007/12/8/medline PY - 2007/9/19/entrez SP - 489 EP - 96 JF - Journal of clinical pharmacy and therapeutics JO - J Clin Pharm Ther VL - 32 IS - 5 N2 - BACKGROUND AND OBJECTIVE: Cystic fibrosis (CF) patients suffer from malabsorption of fat-soluble vitamins (A, D, E and K). These vitamins are available as water-dispersible (A, D(3) and E) or water-soluble grades (K(3)), which is favoured in CF patients as they fail to absorb oil-based products. The objective of this study was to determine stability of these raw materials after opening the original package and to develop a compounded formulation of acceptable quality, stability and taste, allowing flexible dose adaptation and being appropriate for administration to children and elderly people. METHODS: The raw materials were stored after opening their original package for 8 months at 8 degrees C and room temperature (RT). Stability was assessed using a validated HPLC method after extraction of the vitamin from the cold water-soluble matrix (vitamin A acetate, D(3) and E) or using a spectrophotometrical method (vitamin K(3)). These materials were mixed with an appropriate lactose grade (lactose 80 m for vitamins A and D(3); lactose 90 m for vitamin E, lactose very fine powder for vitamin K(3)) and filled in hard gelatin capsules. Mass and content uniformity were determined and stability of the vitamins in the capsules was assessed after 2 months storage at 8 degrees C and RT. RESULTS: All raw materials showed good stability during storage in the opened original package for 8 months storage at 8 degrees C as well as RT (>95% of the initial content). The compounded formulations complied with the requirements of the European Pharmacopoeia for mass and content uniformity and can be stored for 2 months at 8 degrees C or RT while maintaining the vitamin content between 90% and 110%. CONCLUSIONS: As these fat-soluble vitamins are not commercially available on the Belgian market, compounded formulations are a valuable alternative for prophylactic administration of these vitamins to CF patients, i.e. a stable formulation, having an acceptable taste, allowing flexible dose adaptation and being appropriate for administration to children and elderly people. SN - 0269-4727 UR - https://www.unboundmedicine.com/medline/citation/17875116/Compounding_of_vitamin_A_D3_E_and_K3_supplements_for_cystic_fibrosis_patients:_formulation_and_stability_study_ L2 - https://doi.org/10.1111/j.1365-2710.2007.00855.x DB - PRIME DP - Unbound Medicine ER -