The effect of lactose fines, magnesium stearate, choice of mixer and mixing process on the performance of adhesive mixtures for inhalation
(2023) KLGM05 20231Food Technology and Nutrition (M.Sc.)
- Abstract
- Dry powder inhaler (DPI) formulation is a major area of interest since they are employed by the healthcare system to treat relevant chronic diseases like asthma.
Previous research has established that the manufacturing process and formulation composition are key for the active pharmaceutical ingredient to reach the lungs and achieve therapeutic effects. The aim of this study was to research the effect of lactose fines and magnesium stearate as well as mixing processes on the performance of adhesive mixtures for inhalation. The following research work was conducted by employing two mixers: Low shear (Turbula®) and high shear (Diosna®) for the manufacturing of the formulations. Three formulations were prepared varying the amount of... (More) - Dry powder inhaler (DPI) formulation is a major area of interest since they are employed by the healthcare system to treat relevant chronic diseases like asthma.
Previous research has established that the manufacturing process and formulation composition are key for the active pharmaceutical ingredient to reach the lungs and achieve therapeutic effects. The aim of this study was to research the effect of lactose fines and magnesium stearate as well as mixing processes on the performance of adhesive mixtures for inhalation. The following research work was conducted by employing two mixers: Low shear (Turbula®) and high shear (Diosna®) for the manufacturing of the formulations. Three formulations were prepared varying the amount of excipients and mixing time, 27 batches were produced and filled into Novolizer® devices. Micronized budesonide was used as the active pharmaceutical ingredient. Quality control parameters like poured bulk density, drug content assay, and mixing homogeneity were executed. Formulation performance was analyzed by doing particle-size distribution analyses done mostly in an Andersen Cascade Impactor, although Next Generation Impactor was also used. Fine Particle Fraction (FPF) and Fine Particle Dose (FPD) were the central parameters to judge formulation performance. It was found that both lactose fines and magnesium stearate can improve formulation performance. In addition, high shear mixer formulations presented higher FPF values than low shear formulations. These findings suggest that lactose fines and magnesium stearate are key ingredients for an improved formulation performance and that high shear mixing is preferred to enhance FPF for DPIs. (Less) - Popular Abstract
- Dry powder inhaler (DPI) preparation is a key area of interest since they are used by the healthcare system to treat relevant persistent diseases like asthma. Earlier research has shown that the making process and composition of DPI are key for the medicinal ingredient to reach the lungs and have medicinal effects for dry powder inhalers. The objective of this study was to research the effect of the non-medicinal components in the DPI medicine and mixing processes on the ability of the composition to be used in dry powder inhalers and have medicinal value. The following research work was conducted by using two mixers: Low mixing force (Turbula®) and high mixing force (Diosna®) for the fabrication of the preparations. Three preparations... (More)
- Dry powder inhaler (DPI) preparation is a key area of interest since they are used by the healthcare system to treat relevant persistent diseases like asthma. Earlier research has shown that the making process and composition of DPI are key for the medicinal ingredient to reach the lungs and have medicinal effects for dry powder inhalers. The objective of this study was to research the effect of the non-medicinal components in the DPI medicine and mixing processes on the ability of the composition to be used in dry powder inhalers and have medicinal value. The following research work was conducted by using two mixers: Low mixing force (Turbula®) and high mixing force (Diosna®) for the fabrication of the preparations. Three preparations were prepared varying the amount non-medicinal components and mixing time, 27 batches were produced. Small microparticles of budesonide were used as the medicinal ingredient. Quality control considerations like poured powder density, medicine content evaluation, and mixing consistency were done. Preparation performance was analyzed by using equipment that can filter the particles by their size and it is used to predict the preparation ability to reach the lungs. The chosen device was Novolizer®, 27 devices were filled with each preparation. They were connected to this equipment and the powder quantity in each filter was analyzed. It was found that adding small particles of lactose and a non-pharmaceutical ingredient that helps the preparation to have less agglomeration can improve the preparation performance. Also, the high mixing force mixer helped the preparations that were made in this mixer to have more probabilities to reach the lungs, than the ones prepared by the low mixing force mixer. In conclusion, these findings suggest adding small particles of lactose and other nonactive ingredients help the formulation to have less agglomeration thus improving performance. In addition, a high mixing force mixer is necessary to boost preparations for DPIs. (Less)
Please use this url to cite or link to this publication:
http://lup.lub.lu.se/student-papers/record/9121576
- author
- Ponce Aparicio, Gabriela LU
- supervisor
- organization
- course
- KLGM05 20231
- year
- 2023
- type
- H2 - Master's Degree (Two Years)
- subject
- keywords
- High shear mixing, low shear mixing, lactose fines, coating agent, budesonide, mixing energy, dry powder inhaler, carrier-based formulations, mixing time, adhesive mixtures, pharmaceutical technology
- language
- English
- additional info
- Ann-Marie Lyberg was co-supervisor
- id
- 9121576
- date added to LUP
- 2023-06-09 09:11:22
- date last changed
- 2023-06-09 09:11:22
@misc{9121576,
abstract = {{Dry powder inhaler (DPI) formulation is a major area of interest since they are employed by the healthcare system to treat relevant chronic diseases like asthma.
Previous research has established that the manufacturing process and formulation composition are key for the active pharmaceutical ingredient to reach the lungs and achieve therapeutic effects. The aim of this study was to research the effect of lactose fines and magnesium stearate as well as mixing processes on the performance of adhesive mixtures for inhalation. The following research work was conducted by employing two mixers: Low shear (Turbula®) and high shear (Diosna®) for the manufacturing of the formulations. Three formulations were prepared varying the amount of excipients and mixing time, 27 batches were produced and filled into Novolizer® devices. Micronized budesonide was used as the active pharmaceutical ingredient. Quality control parameters like poured bulk density, drug content assay, and mixing homogeneity were executed. Formulation performance was analyzed by doing particle-size distribution analyses done mostly in an Andersen Cascade Impactor, although Next Generation Impactor was also used. Fine Particle Fraction (FPF) and Fine Particle Dose (FPD) were the central parameters to judge formulation performance. It was found that both lactose fines and magnesium stearate can improve formulation performance. In addition, high shear mixer formulations presented higher FPF values than low shear formulations. These findings suggest that lactose fines and magnesium stearate are key ingredients for an improved formulation performance and that high shear mixing is preferred to enhance FPF for DPIs.}},
author = {{Ponce Aparicio, Gabriela}},
language = {{eng}},
note = {{Student Paper}},
title = {{The effect of lactose fines, magnesium stearate, choice of mixer and mixing process on the performance of adhesive mixtures for inhalation}},
year = {{2023}},
}