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Compaction of lactose drug mixtures: quantification of the extent of incompatibility by FT-Raman spectroscopy.
Eur J Pharm Biopharm. 2008 Mar; 68(3):802-10.EJ

Abstract

It is well known that lactoses interact with drugs containing amino groups and undergo the Maillard reaction. Lactose monohydrate may also interact with moisture sensitive drugs and affect the stability of the drug. These interactions were analyzed using three model drugs - Thiaminchloride hydrochloride, Nicotinamide and Acetylsalicylic acid - which interact with spray-dried lactose or anhydrous lactose. FT-Raman spectroscopy was used for the first time to qualitatively and quantitatively analyze these excipient drug interactions in powders and tablets. Both lactoses undergo the Maillard reaction with Thiaminchloride hydrochloride. Nicotinamide did not react with the lactoses because the amide group is protected against the reaction with the lactoses. Only a transition from beta- to alpha-lactose was noticed. The moisture sensitive drug Acetylsalicylic acid remained stable even when the tablets were stored under accelerated conditions (40 degrees C and 75% RH). The crystal water of lactose monohydrate (spray-dried lactose) had no influence on the drug stability but a transition from beta- to alpha-lactose was noticed. In conclusion, FT-Raman spectroscopy is a fast and valuable tool for a quantitative determination of the extents of incompatibility in solid dosage forms.

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Authors+Show Affiliations

Flemming A
Martin-Luther-University Halle-Wittenberg, Institute of Pharmaceutical Technology and Biopharmacy, Halle/Saale, Germany.
Picker-Freyer KM
No affiliation info available

MeSH

AspirinDrug IncompatibilityLactoseNiacinamideSpectrum Analysis, RamanTemperatureThiamine

Pub Type(s)

Journal Article

Language

eng

PubMed ID

17826048

Citation

Flemming, Anett, and Katharina M. Picker-Freyer. "Compaction of Lactose Drug Mixtures: Quantification of the Extent of Incompatibility By FT-Raman Spectroscopy." European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V, vol. 68, no. 3, 2008, pp. 802-10.
Flemming A, Picker-Freyer KM. Compaction of lactose drug mixtures: quantification of the extent of incompatibility by FT-Raman spectroscopy. Eur J Pharm Biopharm. 2008;68(3):802-10.
Flemming, A., & Picker-Freyer, K. M. (2008). Compaction of lactose drug mixtures: quantification of the extent of incompatibility by FT-Raman spectroscopy. European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V, 68(3), 802-10.
Flemming A, Picker-Freyer KM. Compaction of Lactose Drug Mixtures: Quantification of the Extent of Incompatibility By FT-Raman Spectroscopy. Eur J Pharm Biopharm. 2008;68(3):802-10. PubMed PMID: 17826048.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Compaction of lactose drug mixtures: quantification of the extent of incompatibility by FT-Raman spectroscopy. AU - Flemming,Anett, AU - Picker-Freyer,Katharina M, Y1 - 2007/08/08/ PY - 2007/03/30/received PY - 2007/07/26/revised PY - 2007/07/27/accepted PY - 2007/9/11/pubmed PY - 2008/6/11/medline PY - 2007/9/11/entrez SP - 802 EP - 10 JF - European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V JO - Eur J Pharm Biopharm VL - 68 IS - 3 N2 - It is well known that lactoses interact with drugs containing amino groups and undergo the Maillard reaction. Lactose monohydrate may also interact with moisture sensitive drugs and affect the stability of the drug. These interactions were analyzed using three model drugs - Thiaminchloride hydrochloride, Nicotinamide and Acetylsalicylic acid - which interact with spray-dried lactose or anhydrous lactose. FT-Raman spectroscopy was used for the first time to qualitatively and quantitatively analyze these excipient drug interactions in powders and tablets. Both lactoses undergo the Maillard reaction with Thiaminchloride hydrochloride. Nicotinamide did not react with the lactoses because the amide group is protected against the reaction with the lactoses. Only a transition from beta- to alpha-lactose was noticed. The moisture sensitive drug Acetylsalicylic acid remained stable even when the tablets were stored under accelerated conditions (40 degrees C and 75% RH). The crystal water of lactose monohydrate (spray-dried lactose) had no influence on the drug stability but a transition from beta- to alpha-lactose was noticed. In conclusion, FT-Raman spectroscopy is a fast and valuable tool for a quantitative determination of the extents of incompatibility in solid dosage forms. SN - 0939-6411 UR - https://www.unboundmedicine.com/medline/citation/17826048/Compaction_of_lactose_drug_mixtures:_quantification_of_the_extent_of_incompatibility_by_FT_Raman_spectroscopy_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0939-6411(07)00284-6 DB - PRIME DP - Unbound Medicine ER -