Comprehensive study of dynamic curing effect on tablet coating structure

Gendre, Claire; Genty, Muriel; Silva, Júlio César da; Tfayli, Ali; Boiret, Mathieu; Lecoq, Olivier; Baron, Michel; Chaminade, Pierre; Péan, Jean Manuel

doi:10.1016/j.ejpb.2012.04.006

Cited by 27 publications

(21 citation statements)

References 32 publications

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“…For these two cases, powder diffraction data were collected in our laboratory using raw materials which were donated by the pharmaceutical industry. The powder patterns for them are in agreement with that found in the literature (Swaminathan and Kildsig, 2001;Wada and Matsubara, 1994) and (Gendre et al, 2012) respectively. …”

Section: Resultssupporting

confidence: 90%

Atenolol characterization in solid formulations available in Brazilian market

Salvi¹,

Antônio²,

Paiva-Santos³

2013

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Atenolol is the most used drug in Brazil to hypertension treatment. Two crystal structures are known for this molecule: a racemic form (R,S)-atenolol and a pure form S-atenolol. The racemic form is found in commercial tablets. X-ray powder diffraction (XRD) is an adequate tool to study crystalline structures including drugs. Using the Rietveld Method with XRD data it is possible to quantify the crystalline structures existing in the raw material. Other methods like Le Bail and Pawley can be used to the profile fit and phases identification. For this work we analyzed three tablets of atenolol, two generics and the reference (materials were purchased from a drugstore at the city of Araraquara). These tablets were analyzed by Rietveld, Le Bail and Pawley methods. All tablets exhibited the racemic mixture API (R,S)-atenolol. Some crystalline excipients could be characterized: magnesium carbonate hydrate, lactose monohydrate and talc. The conclusion is that the three methods can be efficiently used to characterize the three atenolol tablets.

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Section: Resultssupporting

confidence: 90%

Atenolol characterization in solid formulations available in Brazilian market

Salvi¹,

Antônio²,

Paiva-Santos³

2013

Powder Diffr.

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“…Gendre et al . [24] used X-ray micro-computed tomography to study the curing process of a tablet coating layer. The results revealed a densification of the coating layer with a decrease of the overall coating thickness by about 10 µm.…”

Section: Resultsmentioning

confidence: 99%

Terahertz Pulsed Imaging and Magnetic Resonance Imaging as Tools to Probe Formulation Stability

et al. 2013

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Dissolution stability over the entire shelf life duration is of critical importance to ensure the quality of solid dosage forms. Changes in the drug release profile during storage may affect the bioavailability of drug products. This study investigated the stability of a commercial tablet (Lescol® XL) when stored under accelerated conditions (40 °C/75% r.h.). Terahertz pulsed imaging (TPI) was used to investigate the structure of the tablet coating before and after the accelerated aging process. The results indicate that the coating was reduced in thickness and exhibited a higher density after being stored under accelerated conditions for four weeks. In situ magnetic resonance imaging (MRI) of the water penetration processes during tablet dissolution in a USP-IV dissolution cell equipped with an in-line UV-vis analyzer was carried out to study local differences in water uptake into the tablet matrix between the stressed and unstressed state. The drug release profiles of the Lescol® XL tablet before and after the accelerated storage stability testing were compared using a “difference” factor f1 and a “similarity” factor f2. The results reveal that even though the physical properties of the coating layers changed significantly during the stress testing, the coating protected the tablet matrix and the densification of the coating polymer had no adverse effect on the drug release performance.

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“…In a recent study, a new insight into tablet coating structures along a dynamic curing process, inside a pan coater at 60 • C and ambient relative humidity, was provided (Gendre et al, 2012). Various techniques, such as X-ray micro-computed tomography (XCT), X-ray microdiffraction, as well as near infrared (NIR) and Raman spectroscopies, were jointly used as non-destructive techniques to allow advanced physico-chemical characterization of solid dosage forms.…”

Section: Introductionmentioning

confidence: 99%

Comparative static curing versus dynamic curing on tablet coating structures

Gendre

Genty

Fayard³

et al. 2013

International Journal of Pharmaceutics

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Curing is generally required to stabilize film coating from aqueous polymer dispersion. This post-coating drying step is traditionally carried out in static conditions, requiring the transfer of solid dosage forms to an oven. But, curing operation performed directly inside the coating equipment stands for an attractive industrial application. Recently, the use of various advanced physico-chemical characterization techniques i.e., X-ray micro-computed tomography, vibrational spectroscopies (near infrared and Raman) and X-ray microdiffraction, allowed new insights into the film-coating structures of dynamically cured tablets. Dynamic curing end-point was efficiently determined after 4h. The aim of the present work was to elucidate the influence of curing conditions on film-coating structures. Results demonstrated that 24h of static curing and 4h of dynamic curing, both performed at 60°C and ambient relative humidity, led to similar coating layers in terms of drug release properties, porosity, water content, structural rearrangement of polymer chains and crystalline distribution. Furthermore, X-ray microdiffraction measurements pointed out different crystalline coating compositions depending on sample storage time. An aging mechanism might have occur during storage, resulting in the crystallization and the upward migration of cetyl alcohol, coupled to the downward migration of crystalline sodium lauryl sulfate within the coating layer. Interestingly, this new study clearly provided further knowledge into film-coating structures after a curing step and confirmed that curing operation could be performed in dynamic conditions.

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Comprehensive study of dynamic curing effect on tablet coating structure

Cited by 27 publications

References 32 publications

Atenolol characterization in solid formulations available in Brazilian market

Atenolol characterization in solid formulations available in Brazilian market

Terahertz Pulsed Imaging and Magnetic Resonance Imaging as Tools to Probe Formulation Stability

Comparative static curing versus dynamic curing on tablet coating structures

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