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지문 전체 문장
문장을 클릭하면 해당 문장의 구문 분석 내용을 보여줍니다.
Sprague-Dawley rats from Envigo were used for the study and were acclimated for one week before the study. Particle size/porosity, PLGA ratio, molecular weight, and drug hydrophobicity/hydrophilicity are all properties that have fairly well-established correlations of their impact on performance. Particle size/porosity, L: G ratio, molecular weight, and drug hydrophobicity/hydrophilicity are all properties that have fairly well-established correlations of their impact on performance. The impact of formulation and processing parameters on the resul-tant performance of microparticles is well known. Body weights were taken and recorded at administration and various blood draw time points for ~100 days. The animals were observed for overt toxicity and any existing test site abnormalities during the study, including redness, swelling, bleeding, discharge, and bruising at the injection site. Modifications in formulation and processing parameters have been well documented to produce many resultant differences in properties. Hese three phases correspond to hydration of the microparticle and surface/near-surface drug release, swelling of the microparticle and drug release via constant diffusion, and finally, substantial swelling and degradation where the last and final amounts of the drug are released. Each formulation was given to four rats injected subcutaneously in the scapular region at 50 mg/kg in an aqueous-based vehicle composed of 0.9% sodium chloride, 0.02% Tween 20, and 0.5% sodium carboxymethylcellulose. The 3 in-line batches appear to have a slightly lower percent crystallinity based on the above mentioned areas. The Purdue University Institutional Animal Care and Use Committee approved all animal procedures. As typical with any formulation development program, small-scale bench-top batches were first prepared to determine the critical process parameters that influence the resultant product attributes. Scalability is essential for developing novel PLGA-based products, as this product is susceptible to manufacturing changes. For the internal morphology assessment, microparticles were placed in a -90-degree freezer under sealed conditions, sectioned with a razor blade, and subsequently placed under vacuum in a desiccator to equilibrate to room temperature to avoid any water-induced changes. Also, transferring the seed emulsion into an extraction tank is not often considered at small scales. A difference is noted between the raw polymer and formulation as expected due mainly to the decrease in molecular weight during processing, residual benzyl alcohol, and incorporation of naltrexone into the polymer matrix. Finally, tablets and capsules have multiple on/in-line parameters that can be monitored to ensure a manufacturing process remains within specifi-cation or brought back in (i.e., tablet weight, hardness, blend unifor-mity). Microfluidics offers significant control over potential microparticle properties, although narrow parti-cle size distributions/monodispersity are typically found based upon the microparticle formation mechanism.
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1 Sprague-Dawley rats from Envigo were used for the study and were acclimated for one week before the study. 2 Particle size/porosity, PLGA ratio, molecular weight, and drug hydrophobicity/hydrophilicity are all properties that have fairly well-established correlations of their impact on performance. 3 Particle size/porosity, L: G ratio, molecular weight, and drug hydrophobicity/hydrophilicity are all properties that have fairly well-established correlations of their impact on performance. 4 The impact of formulation and processing parameters on the resul-tant performance of microparticles is well known. 5 Body weights were taken and recorded at administration and various blood draw time points for ~100 days. 6 The animals were observed for overt toxicity and any existing test site abnormalities during the study, including redness, swelling, bleeding, discharge, and bruising at the injection site. 7 Modifications in formulation and processing parameters have been well documented to produce many resultant differences in properties. 8 Hese three phases correspond to hydration of the microparticle and surface/near-surface drug release, swelling of the microparticle and drug release via constant diffusion, and finally, substantial swelling and degradation where the last and final amounts of the drug are released. 9 Each formulation was given to four rats injected subcutaneously in the scapular region at 50 mg/kg in an aqueous-based vehicle composed of 0.9% sodium chloride, 0.02% Tween 20, and 0.5% sodium carboxymethylcellulose. 10 The 3 in-line batches appear to have a slightly lower percent crystallinity based on the above mentioned areas. 11 The Purdue University Institutional Animal Care and Use Committee approved all animal procedures. 12 As typical with any formulation development program, small-scale bench-top batches were first prepared to determine the critical process parameters that influence the resultant product attributes. 13 Scalability is essential for developing novel PLGA-based products, as this product is susceptible to manufacturing changes. 14 For the internal morphology assessment, microparticles were placed in a -90-degree freezer under sealed conditions, sectioned with a razor blade, and subsequently placed under vacuum in a desiccator to equilibrate to room temperature to avoid any water-induced changes. 15 Also, transferring the seed emulsion into an extraction tank is not often considered at small scales. 16 A difference is noted between the raw polymer and formulation as expected due mainly to the decrease in molecular weight during processing, residual benzyl alcohol, and incorporation of naltrexone into the polymer matrix. 17 Finally, tablets and capsules have multiple on/in-line parameters that can be monitored to ensure a manufacturing process remains within specifi-cation or brought back in (i.e., tablet weight, hardness, blend unifor-mity). 18 Microfluidics offers significant control over potential microparticle properties, although narrow parti-cle size distributions/monodispersity are typically found based upon the microparticle formation mechanism.