Special Issue "The 1st Electronic Conference on Pharmaceutical Science"

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A special issue of Pharmaceutics (ISSN 1999-4923).

Deadline for manuscript submissions: closed (30 November 2011)

Special Issue Editor

Guest Editor
Prof. Dr. Jukka Rantanen

University of Copenhagen, Faculty of Health and Medical Sciences, Department of Pharmacy, Universitetsparken 2, 2100 Copenhagen, Denmark
Interests: solid dosage forms; formulation; process analytical technology (PAT) within particulate solids

Special Issue Information

Link to the website: www.sciforum.net/conf/ecps201

Published Papers (2 papers)

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Research

Open AccessArticle Atomic Pairwise Distribution Function Analysis of the Amorphous Phase Prepared by Different Manufacturing Routes
Pharmaceutics 2012, 4(1), 93-103; doi:10.3390/pharmaceutics4010093
Received: 12 December 2011 / Revised: 5 January 2012 / Accepted: 19 January 2012 / Published: 31 January 2012
Cited by 5 | PDF Full-text (295 KB) | HTML Full-text | XML Full-text
Abstract
Amlodipine besilate, a calcium channel antagonist, exists in several solid forms. Processing of anhydrate and dihydrate forms of this drug may lead to solid state changes, and is therefore the focus of this study. Milling was performed for the anhydrate form, whereas [...] Read more.
Amlodipine besilate, a calcium channel antagonist, exists in several solid forms. Processing of anhydrate and dihydrate forms of this drug may lead to solid state changes, and is therefore the focus of this study. Milling was performed for the anhydrate form, whereas the dihydrate form was subjected to quench cooling thereby creating an amorphous form of the drug from both starting materials. The milled and quench cooled samples were, together with the crystalline starting materials, analyzed with X-ray powder diffraction (XRPD), Raman spectroscopy and atomic pair-wise distribution function (PDF) analysis of the XRPD pattern. When compared to XRPD and Raman spectroscopy, the PDF analysis was superior in displaying the difference between the amorphous samples prepared by milling and quench cooling approaches of the two starting materials. Full article
(This article belongs to the Special Issue The 1st Electronic Conference on Pharmaceutical Science)
Open AccessArticle From Mini to Micro Scale—Feasibility of Raman Spectroscopy as a Process Analytical Tool (PAT)
Pharmaceutics 2011, 3(4), 723-730; doi:10.3390/pharmaceutics3040723
Received: 17 August 2011 / Revised: 23 September 2011 / Accepted: 8 October 2011 / Published: 14 October 2011
Cited by 7 | PDF Full-text (315 KB) | HTML Full-text | XML Full-text
Abstract
Background: Active coating is an important unit operation in the pharmaceutical industry. The quality, stability, safety and performance of the final product largely depend on the amount and uniformity of coating applied. Active coating is challenging regarding the total amount of coating [...] Read more.
Background: Active coating is an important unit operation in the pharmaceutical industry. The quality, stability, safety and performance of the final product largely depend on the amount and uniformity of coating applied. Active coating is challenging regarding the total amount of coating and its uniformity. Consequently, there is a strong demand for tools, which are able to monitor and determine the endpoint of a coating operation. In previous work, it was shown that Raman spectroscopy is an appropriate process analytical tool (PAT) to monitor an active spray coating process in a pan coater [1]. Using a multivariate model (Partial Least Squares—PLS) the Raman spectral data could be correlated with the coated amount of the API diprophylline. While the multivariate model was shown to be valid for the process in a mini scale pan coater (batch size: 3.5 kg cores), the aim of the present work was to prove the robustness of the model by transferring the results to tablets coated in a micro scale pan coater (0.5 kg). Method: Coating experiments were performed in both, a mini scale and a micro scale pan coater. The model drug diprophylline was coated on placebo tablets. The multivariate model, established for the process in the mini scale pan coater, was applied to the Raman measurements of tablets coated in the micro scale coater for six different coating levels. Then, the amount of coating, which was predicted by the model, was compared with reference measurements using UV spectroscopy. Results: For all six coating levels the predicted coating amount was equal to the amounts obtained by UV spectroscopy within the statistical error. Thus, it was possible to predict the total coating amount with an error smaller than 3.6%. The root mean squares of errors for calibration and prediction (root mean square of errors for calibration and prediction—RMSEC and RMSEP) were 0.335 mg and 0.392 mg, respectively, which means that the predictive power of the model is not dependent on the scale or the equipment. Conclusion: The scale-down experiment showed that it was possible to transfer the PLS model developed on a mini scale coater to a micro scale coater. Full article
(This article belongs to the Special Issue The 1st Electronic Conference on Pharmaceutical Science)

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