The Experts below are selected from a list of 4812 Experts worldwide ranked by ideXlab platform
Karen M Balwinski - One of the best experts on this subject based on the ideXlab platform.
-
investigation of the effect of Tablet Surface area volume on drug release from hydroxypropylmethylcellulose controlled release matrix Tablets
Drug Development and Industrial Pharmacy, 2002Co-Authors: Thomas Daniel Reynolds, Shawn A Mitchell, Karen M BalwinskiAbstract:ABSTRACTThe purpose of this study was to investigate the influence of Tablet Surface area/volume (SA/Vol) on drug release from controlled-release matrix Tablets containing hydroxypropylmethylcellulose (HPMC). Soluble drugs (promethazine HCl, diphenhydramine HCl, and propranolol HCl) were utilized in this study to give predominantly diffusion-controlled release. Drug release from HPMC matrix Tablets with similar values of SA/Vol was comparable within the same Tablet shape (i.e., flat-faced round Tablets) and among different shapes (i.e., oval, round concave, flat-faced beveled-edge, and flat-faced round Tablets). Tablets having the same Surface area but different SA/Vol values did not result in similar drug release; Tablets with larger SA/Vol values had faster release profiles. Utility of SA/Vol to affect drug release was demonstrated by changing drug doses, and altering Tablet shape to adjust SA/Vol. When SA/Vol was held constant, similar release profiles were obtained with f2 metric values greater than 7...
-
Investigation of the effect of Tablet Surface area/volume on drug release from hydroxypropylmethylcellulose controlled-release matrix Tablets.
Drug development and industrial pharmacy, 2002Co-Authors: Thomas Daniel Reynolds, Shawn A Mitchell, Karen M BalwinskiAbstract:The purpose of this study was to investigate the influence of Tablet Surface area/volume (SA/Vol) on drug release from controlled-release matrix Tablets containing hydroxypropylmethylcellulose (HPMC). Soluble drugs (promethazine HCl, diphenhydramine HCl, and propranolol HCl) were utilized in this study to give predominantly diffusion-controlled release. Drug release from HPMC matrix Tablets with similar values of SA/Vol was comparable within the same Tablet shape (i.e., flat-faced round Tablets) and among different shapes (i.e., oval, round concave, flat-faced beveled-edge, and flat-faced round Tablets). Tablets having the same Surface area but different SA/Vol values did not result in similar drug release; Tablets with larger SA/Vol values hadfaster release profiles. Utility of SA/Vol to affect drug release was demonstrated by changing drug doses, and altering Tablet shape to adjust SA/Vol. When SA/Vol was held constant, similar release profiles were obtained with f2 metric values greater than 70. Thus, Surface area/volume is one of the key variables in controlling drug release from HPMC matrix Tablets. Proper use of this variable has practical application by formulators who may need to duplicate drug release profiles from Tablets of different sizes and different shapes.
-
investigation of the effect of Tablet Surface area volume on drug release from hydroxypropylmethylcellulose controlled release matrix Tablets
Drug Development and Industrial Pharmacy, 2002Co-Authors: Thomas Daniel Reynolds, Shawn A Mitchell, Karen M BalwinskiAbstract:The purpose of this study was to investigate the influence of Tablet Surface area/volume (SA/Vol) on drug release from controlled-release matrix Tablets containing hydroxypropylmethylcellulose (HPMC). Soluble drugs (promethazine HCl, diphenhydramine HCl, and propranolol HCl) were utilized in this study to give predominantly diffusion-controlled release. Drug release from HPMC matrix Tablets with similar values of SA/Vol was comparable within the same Tablet shape (i.e., flat-faced round Tablets) and among different shapes (i.e., oval, round concave, flat-faced beveled-edge, and flat-faced round Tablets). Tablets having the same Surface area but different SA/Vol values did not result in similar drug release; Tablets with larger SA/Vol values hadfaster release profiles. Utility of SA/Vol to affect drug release was demonstrated by changing drug doses, and altering Tablet shape to adjust SA/Vol. When SA/Vol was held constant, similar release profiles were obtained with f2 metric values greater than 70. Thus, Surface area/volume is one of the key variables in controlling drug release from HPMC matrix Tablets. Proper use of this variable has practical application by formulators who may need to duplicate drug release profiles from Tablets of different sizes and different shapes.
Jouko Yliruusi - One of the best experts on this subject based on the ideXlab platform.
-
Fast Tablet Tensile Strength Prediction Based on Non-Invasive Analytics
AAPS PharmSciTech, 2014Co-Authors: Anna Halenius, Satu Lakio, Osmo Antikainen, Juha Hatara, Jouko YliruusiAbstract:In this paper, linkages between Tablet Surface roughness, Tablet compression forces, material properties, and the tensile strength of Tablets were studied. Pure sodium halides (NaF, NaBr, NaCl, and NaI) were chosen as model substances because of their simple and similar structure. Based on the data available in the literature and our own measurements, various models were made to predict the tensile strength of the Tablets. It appeared that only three parameters—Surface roughness, upper punch force, and the true density of material—were needed to predict the tensile strength of a Tablet. Rather surprising was that the Surface roughness alone was capable in the prediction. The used new 3D imaging method (Flash sizer) was roughly a thousand times quicker in determining Tablet Surface roughness than traditionally used laser profilometer. Both methods gave practically analogous results. It is finally suggested that the rapid 3D imaging can be a potential in-line PAT tool to predict mechanical properties of Tablets in production.
-
Effect of Some Excipjents and Compression Pressure on the Adhesion of Aqueous-Based Hydroxypropyl Methylcellulose Film Coatings to Tablet Surface
Drug Development and Industrial Pharmacy, 2008Co-Authors: V.-m. Lehtola, Jyrki Heinämäki, P. Nikupaavo, Jouko YliruusiAbstract:AbstractThe adhesion between aqueous-based hydroxypropyl methylcellulose (HPMC) films and Tablet Surface was evaluated using a Lloyd LRX materials testing machine. Special attention was paid to the effects of compression pressure and the excipients (microcrystalline cellulose, lactose and a commercial combination of lactose and cellulose (CellactoseR)) on the adhesion properties of the film.The adhesion of HPMC films was the lowest for the Tablets containing lactose as a diluent and the highest for the Tablets containing microcrystalline cellulose. The adhesion to CellactoseR-based Tablets increased with increasing compression pressure. With microcrystalline cellulose (MCC) and lactose, the effect of compression pressure on film adhesion was not so clear. The increase in concentration of a hydrophopic lubricant, magnesium stearate, decreased the adhesion between the films and Tablets cores. The greatest decrease was observed with the MCC Tablets.Furthermore the results showed that, the film coating increa...
-
Monitoring Tablet Surface roughness during the film coating process
AAPS PharmSciTech, 2006Co-Authors: Paulus Seitavuopio, Jyrki Heinämäki, Jukka Rantanen, Jouko YliruusiAbstract:The purpose of this study was to evaluate the change of Surface roughness and the development of the film during the film coating process using laser profilometer roughness measurements, SEM imaging, and energy dispersive X-ray (EDX) analysis. Surface roughness and texture changes developing during the process of film coating Tablets were studied by noncontact laser profilometry and scanning electron microscopy (SEM). An EDX analysis was used to monitor the magnesium stearate and titanium dioxide of the Tablets. The Tablet cores were film coated with aqueous hydroxypropyl methylcellulose, and the film coating was performed using an instrumented pilot-scale side-vented drum coater. The SEM images of the film-coated Tablets showed that within the first 30 minutes, the Surface of the Tablet cores was completely covered with a thin film. The magnesium signal that was monitored by SEM-EDX disappeared after ∼15 to 30 minutes, indicating that the Tablet Surface was homogeneously covered with film coating. The Surface roughness started to increase from the beginning of the coating process, and the increase in the roughness broke off after 30 minutes of spraying. The results clearly showed that the Surface roughness of the Tablets increased until the film coating covered the whole Surface area of the Tablets, corresponding to a coating time period of 15 to 30 minutes (from the beginning of the spraying phase). Thereafter, the film only became thicker. The methods used in this study were applicable in the visualization of the changes caused by the film coating on the Tablet Surfaces.
-
Tablet Surface characterisation by various imaging techniques.
International journal of pharmaceutics, 2003Co-Authors: Paulus Seitavuopio, Jukka Rantanen, Jouko YliruusiAbstract:The aim of this study was to characterise Tablet Surfaces using different imaging and roughness analytical techniques including optical microscopy, scanning electron microscopy (SEM), laser profilometry and atomic force microscopy (AFM). The test materials compressed were potassium chloride (KCl) and sodium chloride (NaCl). It was found that all methods used suggested that the KCl Tablets were smoother than the NaCl Tablets and higher compression pressure made the Tablets smoother. Imaging methods like optical microscopy and SEM can give useful information about the roughness of the sample Surface, but they do not provide quantitative information about Surface roughness. Laser profilometry and AFM on the other hand provide quantitative roughness data from two different scales, laser profilometer from 1 mm and atomic force microscope from 90 microm scale. AFM is a powerful technique but other imaging and roughness measuring methods like SEM, optical microscopy and laser profilometry give valuable additional information.
-
Effect of compression force on the crystal properties of erythromycin acistrate Tablets.
European Journal of Pharmaceutics and Biopharmaceutics, 2000Co-Authors: Merja Riippi, Veli-pekka Tanninen, Jouko YliruusiAbstract:Abstract The crystal properties of compressed and powdered erythromycin acistrate Tablets were studied by the X-ray powder diffraction (XRPD) method. Detailed analysis of X-ray powder diffraction line profiles was performed. Diffraction peak intensities and full width at half maximum (FWHM) values of the peaks corresponding to three different crystal lattice directions were determined. Crystallite size was calculated by Scherrer's equation using the data of integral breadth of the peaks. The preferred orientation of the crystallites is also discussed. According to the results, the crystallite size increased on the Tablet Surface after a small compression force (4 kN) in all crystal lattice directions studied. Even small compression forces caused recrystallization. With higher compression forces (8–18 kN) the crystallite size and the FWHM values remained rather constant. After the compression force of 18 kN the peaks in different crystal lattice directions behaved differently. In the lattice directions of diffraction maxima 2 and 3, the effect was the same with the small (4 kN) and the high compression force (22 kN). Further recrystallization occurred with 22 kN. However, in the crystal lattice direction of diffraction maximum 1 at the compression force of 8 kN the crystallite broke and crystallinity decreased. These were not seen in the powdered Tablet samples. It could be concluded that the effect of compression force on the crystal properties of erythromycin acistrate Tablets was seen on the Tablet Surface but not in the powdered Tablets. Compression force also affected the preferred orientation of crystallites on the Tablet Surface and especially in the lattice direction of diffraction maximum 3. This was not seen in the powdered Tablets.
Divyakant Desai - One of the best experts on this subject based on the ideXlab platform.
-
to maintain formulation composition similarity of coated Tablets of different strengths should coating be based on core Tablet weight or Surface area
Pharmaceutical Research, 2020Co-Authors: Jay Poorna Reddy, Gunjan Vyas, Rakshit Patel, Sandeep Rana, Niyaz Mansuri, Jayawickrama Dimuthu, Tejas Shah, Divyakant DesaiAbstract:As per the Japanese or SUPAC guidance to maintain formulation composition similarity across Tablet strengths, the coating should be applied based on the core Tablet Surface area or weight, respectively. These two coating approaches were compared by evaluating protective effects of coating on the light stability of three model compounds. Core Tablets of three light sensitive drugs, nifedipine, rosuvastatin calcium, and montelukast sodium were coated either with PVA-based Opadry® II white or Opadry® II beige. The coated Tablets were exposed to light up to three ICH cycles. For Opadry® II white, the Surface area based coating provided consistent light protection across Tablet strengths when the coating amount was more than 0.1 mg/mm2 compared to that based on core Tablet weights. For Opadry® II beige, both approaches gave comparable and better light protection due to presence of iron oxides. The light protection by Opadry® II white could be because of physical barrier of coating, which was uniform across the strengths when it was based on core Tablet Surface area. For a routine Tablet formulation development with Opadry color coating, it does not matter whether the coating is applied based on the core Tablet Surface area or weight.
-
To Maintain Formulation Composition Similarity of Coated Tablets of Different Strengths: Should Coating be Based on Core Tablet Weight or Surface Area?
Pharmaceutical research, 2020Co-Authors: Jay Poorna Reddy, Gunjan Vyas, Rakshit Patel, Sandeep Rana, Niyaz Mansuri, Jayawickrama Dimuthu, Tejas Shah, Divyakant DesaiAbstract:PURPOSE As per the Japanese or SUPAC guidance to maintain formulation composition similarity across Tablet strengths, the coating should be applied based on the core Tablet Surface area or weight, respectively. These two coating approaches were compared by evaluating protective effects of coating on the light stability of three model compounds. METHODS Core Tablets of three light sensitive drugs, nifedipine, rosuvastatin calcium, and montelukast sodium were coated either with PVA-based Opadry® II white or Opadry® II beige. The coated Tablets were exposed to light up to three ICH cycles. RESULTS For Opadry® II white, the Surface area based coating provided consistent light protection across Tablet strengths when the coating amount was more than 0.1 mg/mm2 compared to that based on core Tablet weights. For Opadry® II beige, both approaches gave comparable and better light protection due to presence of iron oxides. The light protection by Opadry® II white could be because of physical barrier of coating, which was uniform across the strengths when it was based on core Tablet Surface area. CONCLUSION For a routine Tablet formulation development with Opadry color coating, it does not matter whether the coating is applied based on the core Tablet Surface area or weight.
-
assessment of Tablet Surface hardness by laser ablation and its correlation with the erosion tendency of core Tablets
Journal of Pharmaceutical Sciences, 2017Co-Authors: Ajit S Narang, Lydia Breckenridge, Hang Guo, Jennifer Wang, Abraham Avi Wolf, Divyakant Desai, Sailesh A Varia, Sherif BadawyAbstract:Surface erosion of uncoated Tablets results in processing problems such as dusting and defects during coating and is governed by the strength of particle bonding on Tablet Surface. In this study, the correlation between dusting tendency of Tablets in a coating pan with friability and laser ablation Surface hardness was assessed using Tablets containing different concentrations of magnesium stearate and tartaric acid. Surface erosion propensity of different batches was evaluated by assessing their dusting tendency in the coating pan. In addition, all Tablets were analyzed for crushing strength, friability, modified friability test using baffles in the friability apparatus, and weight loss after laser ablation. Tablets with similar crushing strength showed differences in their Surface erosion and dusting tendency when rotated in a coating pan. These differences did not correlate well with Tablet crushing strength or friability but did show reasonably good correlation with mass loss after laser ablation. These results suggest that Tablet Surface mass loss by laser ablation can be used as a minipiloting (small-scale) tool to assess Tablet Surface properties during early stages of drug product development to assess the risk of potential large-scale manufacturing issues.
Thomas Daniel Reynolds - One of the best experts on this subject based on the ideXlab platform.
-
investigation of the effect of Tablet Surface area volume on drug release from hydroxypropylmethylcellulose controlled release matrix Tablets
Drug Development and Industrial Pharmacy, 2002Co-Authors: Thomas Daniel Reynolds, Shawn A Mitchell, Karen M BalwinskiAbstract:ABSTRACTThe purpose of this study was to investigate the influence of Tablet Surface area/volume (SA/Vol) on drug release from controlled-release matrix Tablets containing hydroxypropylmethylcellulose (HPMC). Soluble drugs (promethazine HCl, diphenhydramine HCl, and propranolol HCl) were utilized in this study to give predominantly diffusion-controlled release. Drug release from HPMC matrix Tablets with similar values of SA/Vol was comparable within the same Tablet shape (i.e., flat-faced round Tablets) and among different shapes (i.e., oval, round concave, flat-faced beveled-edge, and flat-faced round Tablets). Tablets having the same Surface area but different SA/Vol values did not result in similar drug release; Tablets with larger SA/Vol values had faster release profiles. Utility of SA/Vol to affect drug release was demonstrated by changing drug doses, and altering Tablet shape to adjust SA/Vol. When SA/Vol was held constant, similar release profiles were obtained with f2 metric values greater than 7...
-
Investigation of the effect of Tablet Surface area/volume on drug release from hydroxypropylmethylcellulose controlled-release matrix Tablets.
Drug development and industrial pharmacy, 2002Co-Authors: Thomas Daniel Reynolds, Shawn A Mitchell, Karen M BalwinskiAbstract:The purpose of this study was to investigate the influence of Tablet Surface area/volume (SA/Vol) on drug release from controlled-release matrix Tablets containing hydroxypropylmethylcellulose (HPMC). Soluble drugs (promethazine HCl, diphenhydramine HCl, and propranolol HCl) were utilized in this study to give predominantly diffusion-controlled release. Drug release from HPMC matrix Tablets with similar values of SA/Vol was comparable within the same Tablet shape (i.e., flat-faced round Tablets) and among different shapes (i.e., oval, round concave, flat-faced beveled-edge, and flat-faced round Tablets). Tablets having the same Surface area but different SA/Vol values did not result in similar drug release; Tablets with larger SA/Vol values hadfaster release profiles. Utility of SA/Vol to affect drug release was demonstrated by changing drug doses, and altering Tablet shape to adjust SA/Vol. When SA/Vol was held constant, similar release profiles were obtained with f2 metric values greater than 70. Thus, Surface area/volume is one of the key variables in controlling drug release from HPMC matrix Tablets. Proper use of this variable has practical application by formulators who may need to duplicate drug release profiles from Tablets of different sizes and different shapes.
-
investigation of the effect of Tablet Surface area volume on drug release from hydroxypropylmethylcellulose controlled release matrix Tablets
Drug Development and Industrial Pharmacy, 2002Co-Authors: Thomas Daniel Reynolds, Shawn A Mitchell, Karen M BalwinskiAbstract:The purpose of this study was to investigate the influence of Tablet Surface area/volume (SA/Vol) on drug release from controlled-release matrix Tablets containing hydroxypropylmethylcellulose (HPMC). Soluble drugs (promethazine HCl, diphenhydramine HCl, and propranolol HCl) were utilized in this study to give predominantly diffusion-controlled release. Drug release from HPMC matrix Tablets with similar values of SA/Vol was comparable within the same Tablet shape (i.e., flat-faced round Tablets) and among different shapes (i.e., oval, round concave, flat-faced beveled-edge, and flat-faced round Tablets). Tablets having the same Surface area but different SA/Vol values did not result in similar drug release; Tablets with larger SA/Vol values hadfaster release profiles. Utility of SA/Vol to affect drug release was demonstrated by changing drug doses, and altering Tablet shape to adjust SA/Vol. When SA/Vol was held constant, similar release profiles were obtained with f2 metric values greater than 70. Thus, Surface area/volume is one of the key variables in controlling drug release from HPMC matrix Tablets. Proper use of this variable has practical application by formulators who may need to duplicate drug release profiles from Tablets of different sizes and different shapes.
Shawn A Mitchell - One of the best experts on this subject based on the ideXlab platform.
-
investigation of the effect of Tablet Surface area volume on drug release from hydroxypropylmethylcellulose controlled release matrix Tablets
Drug Development and Industrial Pharmacy, 2002Co-Authors: Thomas Daniel Reynolds, Shawn A Mitchell, Karen M BalwinskiAbstract:ABSTRACTThe purpose of this study was to investigate the influence of Tablet Surface area/volume (SA/Vol) on drug release from controlled-release matrix Tablets containing hydroxypropylmethylcellulose (HPMC). Soluble drugs (promethazine HCl, diphenhydramine HCl, and propranolol HCl) were utilized in this study to give predominantly diffusion-controlled release. Drug release from HPMC matrix Tablets with similar values of SA/Vol was comparable within the same Tablet shape (i.e., flat-faced round Tablets) and among different shapes (i.e., oval, round concave, flat-faced beveled-edge, and flat-faced round Tablets). Tablets having the same Surface area but different SA/Vol values did not result in similar drug release; Tablets with larger SA/Vol values had faster release profiles. Utility of SA/Vol to affect drug release was demonstrated by changing drug doses, and altering Tablet shape to adjust SA/Vol. When SA/Vol was held constant, similar release profiles were obtained with f2 metric values greater than 7...
-
Investigation of the effect of Tablet Surface area/volume on drug release from hydroxypropylmethylcellulose controlled-release matrix Tablets.
Drug development and industrial pharmacy, 2002Co-Authors: Thomas Daniel Reynolds, Shawn A Mitchell, Karen M BalwinskiAbstract:The purpose of this study was to investigate the influence of Tablet Surface area/volume (SA/Vol) on drug release from controlled-release matrix Tablets containing hydroxypropylmethylcellulose (HPMC). Soluble drugs (promethazine HCl, diphenhydramine HCl, and propranolol HCl) were utilized in this study to give predominantly diffusion-controlled release. Drug release from HPMC matrix Tablets with similar values of SA/Vol was comparable within the same Tablet shape (i.e., flat-faced round Tablets) and among different shapes (i.e., oval, round concave, flat-faced beveled-edge, and flat-faced round Tablets). Tablets having the same Surface area but different SA/Vol values did not result in similar drug release; Tablets with larger SA/Vol values hadfaster release profiles. Utility of SA/Vol to affect drug release was demonstrated by changing drug doses, and altering Tablet shape to adjust SA/Vol. When SA/Vol was held constant, similar release profiles were obtained with f2 metric values greater than 70. Thus, Surface area/volume is one of the key variables in controlling drug release from HPMC matrix Tablets. Proper use of this variable has practical application by formulators who may need to duplicate drug release profiles from Tablets of different sizes and different shapes.
-
investigation of the effect of Tablet Surface area volume on drug release from hydroxypropylmethylcellulose controlled release matrix Tablets
Drug Development and Industrial Pharmacy, 2002Co-Authors: Thomas Daniel Reynolds, Shawn A Mitchell, Karen M BalwinskiAbstract:The purpose of this study was to investigate the influence of Tablet Surface area/volume (SA/Vol) on drug release from controlled-release matrix Tablets containing hydroxypropylmethylcellulose (HPMC). Soluble drugs (promethazine HCl, diphenhydramine HCl, and propranolol HCl) were utilized in this study to give predominantly diffusion-controlled release. Drug release from HPMC matrix Tablets with similar values of SA/Vol was comparable within the same Tablet shape (i.e., flat-faced round Tablets) and among different shapes (i.e., oval, round concave, flat-faced beveled-edge, and flat-faced round Tablets). Tablets having the same Surface area but different SA/Vol values did not result in similar drug release; Tablets with larger SA/Vol values hadfaster release profiles. Utility of SA/Vol to affect drug release was demonstrated by changing drug doses, and altering Tablet shape to adjust SA/Vol. When SA/Vol was held constant, similar release profiles were obtained with f2 metric values greater than 70. Thus, Surface area/volume is one of the key variables in controlling drug release from HPMC matrix Tablets. Proper use of this variable has practical application by formulators who may need to duplicate drug release profiles from Tablets of different sizes and different shapes.