The Experts below are selected from a list of 141 Experts worldwide ranked by ideXlab platform
Stanley M. Shaw - One of the best experts on this subject based on the ideXlab platform.
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The Effect of Formulation on Reduced
2015Co-Authors: Radioiodide Thyroid Uptake, Phd Wen-sheng Huang, Md Chiou-chi Cherng, Stanley M. ShawAbstract:This investigation compared in vitro dissolution profiles from sodium iodide capsules with radioiodide thyroid uptake in pa-tients with thyroid abnormalities, using sodium iodide capsules prepared with a formulation exhibiting complete release of ra-dioiodide in vitro and a formulation exhibiting incomplete re-lease. Methods: In vitro dissolution profiles for radioactive sodium iodide capsules with 2 different formulations were de-termined using the U.S. Pharmacopeia (USP) XXIV dissolution test. The 2 formulations studied in vitro were sodium Phosphate Dibasic powder with 1 % magnesium stearate and Calcium Phosphate Dibasic powder with 3 % magnesium stearate. The thyroid uptake of radioiodide from capsules exhibiting complete release or incomplete release of radioiodide was determined in patients with thyroid disorders. Results: In the dissolution stud-ies, by 20 min after initiation of the test,95 % of the radioactiv
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The Effect of Formulation on Reduced Radioiodide Thyroid Uptake
Journal of nuclear medicine : official publication Society of Nuclear Medicine, 2002Co-Authors: Wen-sheng Huang, Chiou-chi Cherng, Stanley M. ShawAbstract:This investigation compared in vitro dissolution profiles from sodium iodide capsules with radioiodide thyroid uptake in patients with thyroid abnormalities, using sodium iodide capsules prepared with a formulation exhibiting complete release of radioiodide in vitro and a formulation exhibiting incomplete release. Methods: In vitro dissolution profiles for radioactive sodium iodide capsules with 2 different formulations were determined using the U.S. Pharmacopeia (USP) XXIV dissolution test. The 2 formulations studied in vitro were sodium Phosphate Dibasic powder with 1% magnesium stearate and Calcium Phosphate Dibasic powder with 3% magnesium stearate. The thyroid uptake of radioiodide from capsules exhibiting complete release or incomplete release of radioiodide was determined in patients with thyroid disorders. Results: In the dissolution studies, by 20 min after initiation of the test, 95% of the radioactive iodide was released from capsules of sodium Phosphate Dibasic powder. The capsules of Calcium Phosphate Dibasic powder reached 75% at 65 min, with no further release occurring thereafter. In the in vivo studies, the mean thyroid uptake a t1hf or sodium Phosphate Dibasic powder with 1% magnesium stearate (complete-release formulation) was 12.7%, compared with 9.3% for Calcium Phosphate Dibasic powder with 3% magnesium stearate (incomplete-release formulation) (P 0.05). At 24 h, the value was 56.6% for the complete-release formulation, compared with 50.3% for the incomplete-release formulation (P 0.01, Wilcoxon signed rank test). At 1 h, the abdominal activity for the complete-release formulation was 3.4%, compared with 8.8% for the incomplete-release formulation (P 0.01). At 24 h, the value was 0.4% for the complete-release formulation, compared with 1.0% for the incomplete-release formulation (P 0.01). Conclusion: The data suggest that the incomplete dissolution profile observed in vitro may correlate with reduced bioavailability of radioiodide in vivo. The USP dissolution test can be applied to radioiodide sodium iodide capsules as a quality assurance procedure.
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The effect of formulation on radioiodide thyroid uptake in the hyperthyroid cat.
Drug development and industrial pharmacy, 1999Co-Authors: Garnet E. Peck, J. Catharine Scott-moncrieff, William E. Blevins, Stanley M. ShawAbstract:This investigation was designed to compare in vitro dissolution profiles from sodium iodide capsules with radioiodide thyroid uptake in hyperthyroid cats using sodium iodide capsules prepared with a formulation exhibiting a complete release of radioiodide (I-123) in vitro and a formulation with an incomplete release of radioiodide. In vitro dissolution profiles for I-123 sodium iodide capsules with two different formulations were determined using the USP XXIII dissolution test. The two formulations studied in vitro were sodium Phosphate Dibasic powder with 1% magnesium stearate and Calcium Phosphate Dibasic powder with 3% magnesium stearate. By 20 min after initiation of the dissolution test, over 95% of the I-123 was released from capsules of sodium Phosphate Dibasic powder. The capsules of Calcium Phosphate Dibasic powder reached 75% at 65 min, with no further release occurring thereafter. There was a statistically significant difference in the dissolution profiles of the two formulations. The thyroid u...
Masahiro Hirano - One of the best experts on this subject based on the ideXlab platform.
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histological and microradiographic evaluation of hydrated and hardened alpha triCalcium Phosphate Calcium Phosphate Dibasic mixtures
Biomaterials, 1994Co-Authors: Kenji Kurashina, A. Ogiso, Akira Kotani, Hiroyasu Takeuchi, Masahiro HiranoAbstract:Abstract Bone tissue responseto pre-hardened α-triCalcium Phosphate (α-TCP) and Calcium Phosphate Dibasic (DCPD) mixture by hydration was studied histologically and microradiographically after implanting on the inferior aspect of the mandible in rabbits. In 1-month implants, new bone formation was observed along the surface of the material near the host bone, and connection of new and host bone through thin bone bridges was seen in some places. In 3-month implants, newly formed bone filled the greater part of the gap between material and host bone, and in 6-month implants, it surrounded almost all the surface of the material. New bone was in direct contact with the material in all implant periods. The bone response was essentially consistent with that to hydroxyapatite (HA). Resorption of the material was noticed in 3- and 6-month implants. It was concluded that pre-hardened α-TCP/DCPD mixture has good biocompatibility with bone tissue equal to HA and that it resorbs when implanted in rabbit. Further research should be performed to evaluate the material changes of resorption and formation of the white zone.
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Histological and microradiographic evaluation of hydrated and hardened alpha-triCalcium Phosphate/Calcium Phosphate Dibasic mixtures.
Biomaterials, 1994Co-Authors: Kenji Kurashina, A. Ogiso, Akira Kotani, Hiroyasu Takeuchi, Masahiro HiranoAbstract:Abstract Bone tissue responseto pre-hardened α-triCalcium Phosphate (α-TCP) and Calcium Phosphate Dibasic (DCPD) mixture by hydration was studied histologically and microradiographically after implanting on the inferior aspect of the mandible in rabbits. In 1-month implants, new bone formation was observed along the surface of the material near the host bone, and connection of new and host bone through thin bone bridges was seen in some places. In 3-month implants, newly formed bone filled the greater part of the gap between material and host bone, and in 6-month implants, it surrounded almost all the surface of the material. New bone was in direct contact with the material in all implant periods. The bone response was essentially consistent with that to hydroxyapatite (HA). Resorption of the material was noticed in 3- and 6-month implants. It was concluded that pre-hardened α-TCP/DCPD mixture has good biocompatibility with bone tissue equal to HA and that it resorbs when implanted in rabbit. Further research should be performed to evaluate the material changes of resorption and formation of the white zone.
Fernando J Muzzio - One of the best experts on this subject based on the ideXlab platform.
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formulation and manufacture of pharmaceuticals by fluidized bed impregnation of active pharmaceutical ingredients onto porous carriers
Aiche Journal, 2013Co-Authors: Plamen I Grigorov, Benjamin J Glasser, Fernando J MuzzioAbstract:A manufacturing method is presented for solid dosage forms using fluidized-bed impregnation, which could eliminate many of the challenges during solid dosage manufacturing. The main difference between impregnation and dry blending is the placement of the active pharmaceutical ingredient (API) inside a porous carrier. This makes the final material flow properties independent of the physical properties of the API. The method consists of spraying an API solution in appropriate solvent onto a carefully chosen porous excipient in a fluidized state. The solution penetrates the porous carrier due to capillary forces and the solvent is evaporated soon after that. Impregnation and drying occur simultaneously, which makes this impregnation method suitable for continuous implementation. Carefully choosing the operating conditions allows impregnation to occur without introducing spray drying or spray coating of the API. The method is shown to generate an impregnated excipient with very high degree of homogeneity independent of the API loading. It is also shown that mild milling further improves blend uniformity to RSD levels below 1%, which are challenging to achieve using conventional techniques. On impregnation, the final physical properties of the material are seen to be mainly unchanged from the initial excipient properties. A study of this one-step manufacturing method is described, using acetaminophen as the model drug and anhydrous Calcium Phosphate Dibasic as the porous excipient. The experimental work presented establishes a proof of concept and investigates in detail blend uniformity, physical state of impregnated API, final physical properties of impregnated material, compressibility during tableting, capsule filling, and release profile of the final capsule formulation. It also discusses potential ways for drug release control and improvements using impregnation. © 2013 American Institute of Chemical Engineers AIChE J, 59: 4538–4552, 2013
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Formulation and manufacture of pharmaceuticals by fluidized‐bed impregnation of active pharmaceutical ingredients onto porous carriers
AIChE Journal, 2013Co-Authors: Plamen I Grigorov, Benjamin J Glasser, Fernando J MuzzioAbstract:A manufacturing method is presented for solid dosage forms using fluidized-bed impregnation, which could eliminate many of the challenges during solid dosage manufacturing. The main difference between impregnation and dry blending is the placement of the active pharmaceutical ingredient (API) inside a porous carrier. This makes the final material flow properties independent of the physical properties of the API. The method consists of spraying an API solution in appropriate solvent onto a carefully chosen porous excipient in a fluidized state. The solution penetrates the porous carrier due to capillary forces and the solvent is evaporated soon after that. Impregnation and drying occur simultaneously, which makes this impregnation method suitable for continuous implementation. Carefully choosing the operating conditions allows impregnation to occur without introducing spray drying or spray coating of the API. The method is shown to generate an impregnated excipient with very high degree of homogeneity independent of the API loading. It is also shown that mild milling further improves blend uniformity to RSD levels below 1%, which are challenging to achieve using conventional techniques. On impregnation, the final physical properties of the material are seen to be mainly unchanged from the initial excipient properties. A study of this one-step manufacturing method is described, using acetaminophen as the model drug and anhydrous Calcium Phosphate Dibasic as the porous excipient. The experimental work presented establishes a proof of concept and investigates in detail blend uniformity, physical state of impregnated API, final physical properties of impregnated material, compressibility during tableting, capsule filling, and release profile of the final capsule formulation. It also discusses potential ways for drug release control and improvements using impregnation. © 2013 American Institute of Chemical Engineers AIChE J, 59: 4538–4552, 2013
Plamen I Grigorov - One of the best experts on this subject based on the ideXlab platform.
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formulation and manufacture of pharmaceuticals by fluidized bed impregnation of active pharmaceutical ingredients onto porous carriers
Aiche Journal, 2013Co-Authors: Plamen I Grigorov, Benjamin J Glasser, Fernando J MuzzioAbstract:A manufacturing method is presented for solid dosage forms using fluidized-bed impregnation, which could eliminate many of the challenges during solid dosage manufacturing. The main difference between impregnation and dry blending is the placement of the active pharmaceutical ingredient (API) inside a porous carrier. This makes the final material flow properties independent of the physical properties of the API. The method consists of spraying an API solution in appropriate solvent onto a carefully chosen porous excipient in a fluidized state. The solution penetrates the porous carrier due to capillary forces and the solvent is evaporated soon after that. Impregnation and drying occur simultaneously, which makes this impregnation method suitable for continuous implementation. Carefully choosing the operating conditions allows impregnation to occur without introducing spray drying or spray coating of the API. The method is shown to generate an impregnated excipient with very high degree of homogeneity independent of the API loading. It is also shown that mild milling further improves blend uniformity to RSD levels below 1%, which are challenging to achieve using conventional techniques. On impregnation, the final physical properties of the material are seen to be mainly unchanged from the initial excipient properties. A study of this one-step manufacturing method is described, using acetaminophen as the model drug and anhydrous Calcium Phosphate Dibasic as the porous excipient. The experimental work presented establishes a proof of concept and investigates in detail blend uniformity, physical state of impregnated API, final physical properties of impregnated material, compressibility during tableting, capsule filling, and release profile of the final capsule formulation. It also discusses potential ways for drug release control and improvements using impregnation. © 2013 American Institute of Chemical Engineers AIChE J, 59: 4538–4552, 2013
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Formulation and manufacture of pharmaceuticals by fluidized‐bed impregnation of active pharmaceutical ingredients onto porous carriers
AIChE Journal, 2013Co-Authors: Plamen I Grigorov, Benjamin J Glasser, Fernando J MuzzioAbstract:A manufacturing method is presented for solid dosage forms using fluidized-bed impregnation, which could eliminate many of the challenges during solid dosage manufacturing. The main difference between impregnation and dry blending is the placement of the active pharmaceutical ingredient (API) inside a porous carrier. This makes the final material flow properties independent of the physical properties of the API. The method consists of spraying an API solution in appropriate solvent onto a carefully chosen porous excipient in a fluidized state. The solution penetrates the porous carrier due to capillary forces and the solvent is evaporated soon after that. Impregnation and drying occur simultaneously, which makes this impregnation method suitable for continuous implementation. Carefully choosing the operating conditions allows impregnation to occur without introducing spray drying or spray coating of the API. The method is shown to generate an impregnated excipient with very high degree of homogeneity independent of the API loading. It is also shown that mild milling further improves blend uniformity to RSD levels below 1%, which are challenging to achieve using conventional techniques. On impregnation, the final physical properties of the material are seen to be mainly unchanged from the initial excipient properties. A study of this one-step manufacturing method is described, using acetaminophen as the model drug and anhydrous Calcium Phosphate Dibasic as the porous excipient. The experimental work presented establishes a proof of concept and investigates in detail blend uniformity, physical state of impregnated API, final physical properties of impregnated material, compressibility during tableting, capsule filling, and release profile of the final capsule formulation. It also discusses potential ways for drug release control and improvements using impregnation. © 2013 American Institute of Chemical Engineers AIChE J, 59: 4538–4552, 2013
Garnet E. Peck - One of the best experts on this subject based on the ideXlab platform.
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The effect of formulation on radioiodide thyroid uptake in the hyperthyroid cat.
Drug development and industrial pharmacy, 1999Co-Authors: Garnet E. Peck, J. Catharine Scott-moncrieff, William E. Blevins, Stanley M. ShawAbstract:This investigation was designed to compare in vitro dissolution profiles from sodium iodide capsules with radioiodide thyroid uptake in hyperthyroid cats using sodium iodide capsules prepared with a formulation exhibiting a complete release of radioiodide (I-123) in vitro and a formulation with an incomplete release of radioiodide. In vitro dissolution profiles for I-123 sodium iodide capsules with two different formulations were determined using the USP XXIII dissolution test. The two formulations studied in vitro were sodium Phosphate Dibasic powder with 1% magnesium stearate and Calcium Phosphate Dibasic powder with 3% magnesium stearate. By 20 min after initiation of the dissolution test, over 95% of the I-123 was released from capsules of sodium Phosphate Dibasic powder. The capsules of Calcium Phosphate Dibasic powder reached 75% at 65 min, with no further release occurring thereafter. There was a statistically significant difference in the dissolution profiles of the two formulations. The thyroid u...
