Michael Riebe - Academia.edu (original) (raw)

Papers by Michael Riebe

Research paper thumbnail of P293 Drug delivery performance of budesonide (BD), glycopyrronium (GP) and formoterol (FF) triple combination (BGF) co-suspension™ delivery technology mdis

Thorax, 2016

At day 0 and appropriate time intervals until the final dose was dispensed and the lock-out mecha... more At day 0 and appropriate time intervals until the final dose was dispensed and the lock-out mechanism of the inhaler was activated, the following parameters were assessed: water content, degradation products, content per cartridge, delivered dose (DD), fine particle dose (FPD) and microbial growth. All results, notably DD and FPD (Figure 1), were within the expected range and well inside the specifications applied during development. More precisely, the mean results of DD for aclidinium bromide were between 370 mg and 451 mg (specification 320-480 mg) and for FPD between 139 mg and 182 mg (specification 80mg), while the mean values of DD for formoterol fumarate dihydrate were between 10.1 mg and 13.1 mg (specification 9.6-14.4 mg) and for FPD between 2.5 mg and 3.7 mg (specification 1.8 mg). The studies show that stable pharmaceutical quality can be guaranteed under in-use conditions for a period longer than the allowed 60 days after unpacking the drug product pre-stored even up to the end of shelf life. *Registered trademark of AstraZeneca group of companies; for use within the USA as Pressair ® and Genuair™ within all other licensed territories.

Research paper thumbnail of Inhalateur doseur de dipropionate de beclomethasone

Cet inhalateur doseur est dote de surfaces internes partiellement ou totalement recouvertes d&#39... more Cet inhalateur doseur est dote de surfaces internes partiellement ou totalement recouvertes d'un ou de plusieurs polymeres fluorocarbones, eventuellement combines avec un ou plusieurs polymeres non fluorocarbones, ce qui permet l'inhalation d'une formulation medicamenteuse comprenant du dipropionate de becomethasone ou un de ses sels physiologiquement acceptables, et il contient un propulseur fluorocarbone, eventuellement combine avec un ou plusieurs autres agents pharmacologiquement actifs et un ou plusieurs excipients.

Research paper thumbnail of Mért dózist adagoló inhalálóberendezés

Research paper thumbnail of Soupape pour recipient diffuseur d'aerosol

L'invention porte sur une soupape pour recipients diffuseur d'aerosol, concue pour en dif... more L'invention porte sur une soupape pour recipients diffuseur d'aerosol, concue pour en diffuser une partie du contenu. Les composants de la soupape sont en polymere fluore et/ou revetus de polymere fluore, ce qui s'est avere reduire les depots de medicaments sur la soupape.

Research paper thumbnail of Metered Dose Inhaler a Metered Dose Inhaler System and Use Thereof

Research paper thumbnail of Inhalation device options for the management of chronic obstructive pulmonary disease

Postgraduate Medicine, 2017

ABSTRACT Chronic obstructive pulmonary disease (COPD) is characterized by chronic respiratory sym... more ABSTRACT Chronic obstructive pulmonary disease (COPD) is characterized by chronic respiratory symptoms and airflow limitation, resulting from abnormalities in the airway and/or damage to the alveoli. Primary care physicians manage the healthcare of a large proportion of patients with COPD. In addition to determining the most appropriate medication regimen, which usually includes inhaled bronchodilators with or without inhaled corticosteroids, physicians are charged with optimizing inhalation device selection to facilitate effective drug delivery and patient adherence. The large variety of inhalation devices currently available present numerous challenges for physicians that include: (1) gaining knowledge of and proficiency with operating different device classes; (2) identifying the most appropriate inhalation device for the patient; and (3) providing the necessary education and training for patients on device use. This review provides an overview of the inhalation device types currently available in the United States for delivery of COPD medications, including information on their successful operation and respective advantages and disadvantages, factors to consider in matching a device to an individual patient, the need for device training for patients and physicians, and guidance for improving treatment adherence. Finally, the review will discuss established and novel tools and technology that may aid physicians in improving education and promoting better adherence to therapy.

Research paper thumbnail of Valve for aerosol container

Research paper thumbnail of Aerosol Container Comprising a Valve

Research paper thumbnail of Elimination of inhomogeneous broadening in low-temperature mixed organic crystals using fully resonant four-wave mixing spectroscopy (A)

Research paper thumbnail of A matrixed approach to long‐term stability testing of pharmaceutical products

Journal of Pharmaceutical Sciences, 1996

A matrixed approach to long-term stability testing of pharmaceutical products is presented. The b... more A matrixed approach to long-term stability testing of pharmaceutical products is presented. The basic matrix design, suitable for testing three lots at one storage condition, may be extended to multiple product presentations or storage conditions. The design has full testing at the endpoints (0 and 36 months) and partial testing at the interim time points (3, 6, 9, 12, 18, and 24 months). The test points were selected with the assistance of a statistical search algorithm. The proposed matrix design provides a 37.5% reduction in analytical testing, while still permitting a reliable interim expiry estimate based on 12-month stability data. The expiration dating periods estimated using the matrixed approach are typically more conservative than estimates derived from a full-testing approach. A comparison of expiration dating period estimates for a metered-dose inhaler and capsule drug product using the matrixed and full-testing approaches is presented.

Research paper thumbnail of Demonstration of four wave mixing line narrowing spectroscopy - the nonlinear analogue of fluorescence line narrowing

Journal of Luminescence, 1988

Abstract Fully resonant four wave mixing techniques have been developed that have the same site s... more Abstract Fully resonant four wave mixing techniques have been developed that have the same site selective capabilities as laser excited fluorescence and laser induced fluorescence line narrowing.

Research paper thumbnail of Comparisons between 2D doubly vibrationally enhanced four wave mixing and site selective spectroscopy

Journal of Luminescence, 2000

We have constructed a nonlinear spectroscopic system for performing multiresonant four-wave mixin... more We have constructed a nonlinear spectroscopic system for performing multiresonant four-wave mixing with infrared lasers. The system consists of three coherent sources, two of which are tunable in the infrared region of the spectrum. The sources are tuned to different ...

Research paper thumbnail of Spectral line-narrowing and saturation effects in fully resonant nondegenerate four wave mixing

The Journal of Chemical Physics, 1988

Pentacene doped benzoic acid crystals are used to study the line-narrowing capability of fully re... more Pentacene doped benzoic acid crystals are used to study the line-narrowing capability of fully resonant four wave mixing for inhomogeneously broadened transitions. Both parametric and nonparametric nonlinear spectroscopies are used to scan the vibronic resonances of excited electronic states while maintaining resonance with a vibrational mode of the ground state and the vibrationless level of the excited state. The observed vibronic transitions correspond to modes that are coupled to the ground state mode. The spectra contain both lines that are narrowed and lines that have the full inhomogeneous width. Narrowing of the vibronic transitions is observed when site selection is performed on the vibrationless electronic transition in both parametric and nonparametric methods. Narrowing of the vibrational resonance is not observed under the same conditions showing that the vibrational and electronic inhomogeneous broadenings are not correlated. The shifts of the line positions and the ch...

Research paper thumbnail of Molecular, multiresonant coherent four-wave mixing spectroscopy

International Reviews in Physical Chemistry, 1991

Page 1. INTERNATIONAL REVIEWS IN PHYSICAL CHEMISTRY, 1991, VOL. 10, No. 4, 349-390 Molecular, mul... more Page 1. INTERNATIONAL REVIEWS IN PHYSICAL CHEMISTRY, 1991, VOL. 10, No. 4, 349-390 Molecular, multiresonant coherent four-wave mixing spectroscopy? by JOHN C. WRIGHT, ROGER J. CARLSON, GREGORY B ...

Research paper thumbnail of Non-linear line-narrowing spectroscopy in mixed organic crystals

Chemical Physics Letters, 1987

Abstract We report the elimination of inhomogeneous broadening in mixed organic crystals with mul... more Abstract We report the elimination of inhomogeneous broadening in mixed organic crystals with multiply resonant four-wave mixing methods. Line narrowing and the line shifts characteristic of site selective methods are observed for both coherent anti-Stokes Raman spectroscopy (CARS) and multiply enhanced non-parametric spectrosocopy (MENS). The site selective capability of CARS is in agreement with the model proposed by Ouellette and Denariez-Roberge.

Research paper thumbnail of Pharmaceutical transition to non-CFC pressurized metered dose inhalers

Respiratory Medicine, 2000

The production of ozone-depleting chlorofluorocarbons (CFCs) was discontinued on 1 January 1996 f... more The production of ozone-depleting chlorofluorocarbons (CFCs) was discontinued on 1 January 1996 for all uses deemed non-essential under the Montreal Protocol. However, the use of CFCs as propellants in pressurized metered dose inhalers (pMDIs) was classed as essential, providing an exemption from the agreement. Following extensive research, the hydrofluoroalkanes (HFA) 134a and 227 were identified as the only suitable replacements for CFC propellants in pMDIs. The drug delivery of pMDIs formulated with HFA 134a as a propellant and containing either salbutamol (100 #g per actuation) or fluticasone propionate (125 and 250/ag per actuation) have been assessed for dose uniformity and particle size distribution. All of the HFA 134a pMDIs delivered doses throughout the life of the canisters that were reproducible and within specified regulatory requirements. Each of the products provided an emitted dose which was within +25% of the mean value indicating accurate and consistent dosing (93, 112 and 221 ltg per metered dose for the salbutamol 100/2g and fluticasone propionate 125 and 250/~g HFA 134a pMDIs, respectively). These findings were unaffected by changing the storage orientation of the pMDI or by using the device in a manner designed to simulate typical patient use. The particle size distributions of HFA 134a pMDI doses did not differ significantly from those of the corresponding CFC pMDIs. As a result of the similar pharmaceutical performance, it is unnecessary to change the label claim dose of active drug when making the transition from a CFC to an HFA 134a pMDI for salbutamol (Ventolin TM) and fluticasone propionate (FlixotideXM). A seamless transition to non-CFC pMDIs will help to maintain the confidence of patients and healthcare professionals in asthma therapy.

Research paper thumbnail of A metered dose inhaler of salmeterol

Research paper thumbnail of Metered dose inhaler Albuterol

Research paper thumbnail of Dosing Inhibitor for Albuterol

SE DESCRIBE UN INHALADOR DE DOSIS MEDIDA QUE PRESENTA TODAS O PARTE DE SUS SUPERFICIES INTERNAS R... more SE DESCRIBE UN INHALADOR DE DOSIS MEDIDA QUE PRESENTA TODAS O PARTE DE SUS SUPERFICIES INTERNAS RECUBIERTAS CON UNO O MAS POLIMEROS DE FLUOROCARBONO, OPCIONALMENTE EN COMBINACION CON UNO O MAS POLIMEROS NO FLUOROCARBONADOS, PARA LA DISPENSACION DE UNA FORMULACION DE FARMACO DE INHALACION QUE CONTIENE ALBUTEROL O UNA SAL FISIOLOGICAMENTE ACEPTABLE DEL MISMO, Y UN PROPELENTE DE FLUOROCARBONO, OPCIONALMENTE EN COMBINACION CON UNO O MAS AGENTES ACTIVOS FARMACOLOGICAMENTE Y UNO O MAS EXCIPIENTES.

Research paper thumbnail of MDI beclomethasone dipropionate

DESCRIBED A Metered Dose Inhaler HOLDING ALL OR PART OF YOUR INNER surface coated with one or mor... more DESCRIBED A Metered Dose Inhaler HOLDING ALL OR PART OF YOUR INNER surface coated with one or more fluorocarbon polymers, optionally in combination with one or more non-fluorocarbon polymers, for dispensing a drug formulation inhalable COMPRISING beclomethasone dipropionate OR solvate physiologically acceptable thereof, and a fluorocarbon propellant, optionally in combination with one or more pharmacologically AGENTS assets or one or more excipients.

Research paper thumbnail of P293 Drug delivery performance of budesonide (BD), glycopyrronium (GP) and formoterol (FF) triple combination (BGF) co-suspension™ delivery technology mdis

Thorax, 2016

At day 0 and appropriate time intervals until the final dose was dispensed and the lock-out mecha... more At day 0 and appropriate time intervals until the final dose was dispensed and the lock-out mechanism of the inhaler was activated, the following parameters were assessed: water content, degradation products, content per cartridge, delivered dose (DD), fine particle dose (FPD) and microbial growth. All results, notably DD and FPD (Figure 1), were within the expected range and well inside the specifications applied during development. More precisely, the mean results of DD for aclidinium bromide were between 370 mg and 451 mg (specification 320-480 mg) and for FPD between 139 mg and 182 mg (specification 80mg), while the mean values of DD for formoterol fumarate dihydrate were between 10.1 mg and 13.1 mg (specification 9.6-14.4 mg) and for FPD between 2.5 mg and 3.7 mg (specification 1.8 mg). The studies show that stable pharmaceutical quality can be guaranteed under in-use conditions for a period longer than the allowed 60 days after unpacking the drug product pre-stored even up to the end of shelf life. *Registered trademark of AstraZeneca group of companies; for use within the USA as Pressair ® and Genuair™ within all other licensed territories.

Research paper thumbnail of Inhalateur doseur de dipropionate de beclomethasone

Cet inhalateur doseur est dote de surfaces internes partiellement ou totalement recouvertes d&#39... more Cet inhalateur doseur est dote de surfaces internes partiellement ou totalement recouvertes d'un ou de plusieurs polymeres fluorocarbones, eventuellement combines avec un ou plusieurs polymeres non fluorocarbones, ce qui permet l'inhalation d'une formulation medicamenteuse comprenant du dipropionate de becomethasone ou un de ses sels physiologiquement acceptables, et il contient un propulseur fluorocarbone, eventuellement combine avec un ou plusieurs autres agents pharmacologiquement actifs et un ou plusieurs excipients.

Research paper thumbnail of Mért dózist adagoló inhalálóberendezés

Research paper thumbnail of Soupape pour recipient diffuseur d'aerosol

L'invention porte sur une soupape pour recipients diffuseur d'aerosol, concue pour en dif... more L'invention porte sur une soupape pour recipients diffuseur d'aerosol, concue pour en diffuser une partie du contenu. Les composants de la soupape sont en polymere fluore et/ou revetus de polymere fluore, ce qui s'est avere reduire les depots de medicaments sur la soupape.

Research paper thumbnail of Metered Dose Inhaler a Metered Dose Inhaler System and Use Thereof

Research paper thumbnail of Inhalation device options for the management of chronic obstructive pulmonary disease

Postgraduate Medicine, 2017

ABSTRACT Chronic obstructive pulmonary disease (COPD) is characterized by chronic respiratory sym... more ABSTRACT Chronic obstructive pulmonary disease (COPD) is characterized by chronic respiratory symptoms and airflow limitation, resulting from abnormalities in the airway and/or damage to the alveoli. Primary care physicians manage the healthcare of a large proportion of patients with COPD. In addition to determining the most appropriate medication regimen, which usually includes inhaled bronchodilators with or without inhaled corticosteroids, physicians are charged with optimizing inhalation device selection to facilitate effective drug delivery and patient adherence. The large variety of inhalation devices currently available present numerous challenges for physicians that include: (1) gaining knowledge of and proficiency with operating different device classes; (2) identifying the most appropriate inhalation device for the patient; and (3) providing the necessary education and training for patients on device use. This review provides an overview of the inhalation device types currently available in the United States for delivery of COPD medications, including information on their successful operation and respective advantages and disadvantages, factors to consider in matching a device to an individual patient, the need for device training for patients and physicians, and guidance for improving treatment adherence. Finally, the review will discuss established and novel tools and technology that may aid physicians in improving education and promoting better adherence to therapy.

Research paper thumbnail of Valve for aerosol container

Research paper thumbnail of Aerosol Container Comprising a Valve

Research paper thumbnail of Elimination of inhomogeneous broadening in low-temperature mixed organic crystals using fully resonant four-wave mixing spectroscopy (A)

Research paper thumbnail of A matrixed approach to long‐term stability testing of pharmaceutical products

Journal of Pharmaceutical Sciences, 1996

A matrixed approach to long-term stability testing of pharmaceutical products is presented. The b... more A matrixed approach to long-term stability testing of pharmaceutical products is presented. The basic matrix design, suitable for testing three lots at one storage condition, may be extended to multiple product presentations or storage conditions. The design has full testing at the endpoints (0 and 36 months) and partial testing at the interim time points (3, 6, 9, 12, 18, and 24 months). The test points were selected with the assistance of a statistical search algorithm. The proposed matrix design provides a 37.5% reduction in analytical testing, while still permitting a reliable interim expiry estimate based on 12-month stability data. The expiration dating periods estimated using the matrixed approach are typically more conservative than estimates derived from a full-testing approach. A comparison of expiration dating period estimates for a metered-dose inhaler and capsule drug product using the matrixed and full-testing approaches is presented.

Research paper thumbnail of Demonstration of four wave mixing line narrowing spectroscopy - the nonlinear analogue of fluorescence line narrowing

Journal of Luminescence, 1988

Abstract Fully resonant four wave mixing techniques have been developed that have the same site s... more Abstract Fully resonant four wave mixing techniques have been developed that have the same site selective capabilities as laser excited fluorescence and laser induced fluorescence line narrowing.

Research paper thumbnail of Comparisons between 2D doubly vibrationally enhanced four wave mixing and site selective spectroscopy

Journal of Luminescence, 2000

We have constructed a nonlinear spectroscopic system for performing multiresonant four-wave mixin... more We have constructed a nonlinear spectroscopic system for performing multiresonant four-wave mixing with infrared lasers. The system consists of three coherent sources, two of which are tunable in the infrared region of the spectrum. The sources are tuned to different ...

Research paper thumbnail of Spectral line-narrowing and saturation effects in fully resonant nondegenerate four wave mixing

The Journal of Chemical Physics, 1988

Pentacene doped benzoic acid crystals are used to study the line-narrowing capability of fully re... more Pentacene doped benzoic acid crystals are used to study the line-narrowing capability of fully resonant four wave mixing for inhomogeneously broadened transitions. Both parametric and nonparametric nonlinear spectroscopies are used to scan the vibronic resonances of excited electronic states while maintaining resonance with a vibrational mode of the ground state and the vibrationless level of the excited state. The observed vibronic transitions correspond to modes that are coupled to the ground state mode. The spectra contain both lines that are narrowed and lines that have the full inhomogeneous width. Narrowing of the vibronic transitions is observed when site selection is performed on the vibrationless electronic transition in both parametric and nonparametric methods. Narrowing of the vibrational resonance is not observed under the same conditions showing that the vibrational and electronic inhomogeneous broadenings are not correlated. The shifts of the line positions and the ch...

Research paper thumbnail of Molecular, multiresonant coherent four-wave mixing spectroscopy

International Reviews in Physical Chemistry, 1991

Page 1. INTERNATIONAL REVIEWS IN PHYSICAL CHEMISTRY, 1991, VOL. 10, No. 4, 349-390 Molecular, mul... more Page 1. INTERNATIONAL REVIEWS IN PHYSICAL CHEMISTRY, 1991, VOL. 10, No. 4, 349-390 Molecular, multiresonant coherent four-wave mixing spectroscopy? by JOHN C. WRIGHT, ROGER J. CARLSON, GREGORY B ...

Research paper thumbnail of Non-linear line-narrowing spectroscopy in mixed organic crystals

Chemical Physics Letters, 1987

Abstract We report the elimination of inhomogeneous broadening in mixed organic crystals with mul... more Abstract We report the elimination of inhomogeneous broadening in mixed organic crystals with multiply resonant four-wave mixing methods. Line narrowing and the line shifts characteristic of site selective methods are observed for both coherent anti-Stokes Raman spectroscopy (CARS) and multiply enhanced non-parametric spectrosocopy (MENS). The site selective capability of CARS is in agreement with the model proposed by Ouellette and Denariez-Roberge.

Research paper thumbnail of Pharmaceutical transition to non-CFC pressurized metered dose inhalers

Respiratory Medicine, 2000

The production of ozone-depleting chlorofluorocarbons (CFCs) was discontinued on 1 January 1996 f... more The production of ozone-depleting chlorofluorocarbons (CFCs) was discontinued on 1 January 1996 for all uses deemed non-essential under the Montreal Protocol. However, the use of CFCs as propellants in pressurized metered dose inhalers (pMDIs) was classed as essential, providing an exemption from the agreement. Following extensive research, the hydrofluoroalkanes (HFA) 134a and 227 were identified as the only suitable replacements for CFC propellants in pMDIs. The drug delivery of pMDIs formulated with HFA 134a as a propellant and containing either salbutamol (100 #g per actuation) or fluticasone propionate (125 and 250/ag per actuation) have been assessed for dose uniformity and particle size distribution. All of the HFA 134a pMDIs delivered doses throughout the life of the canisters that were reproducible and within specified regulatory requirements. Each of the products provided an emitted dose which was within +25% of the mean value indicating accurate and consistent dosing (93, 112 and 221 ltg per metered dose for the salbutamol 100/2g and fluticasone propionate 125 and 250/~g HFA 134a pMDIs, respectively). These findings were unaffected by changing the storage orientation of the pMDI or by using the device in a manner designed to simulate typical patient use. The particle size distributions of HFA 134a pMDI doses did not differ significantly from those of the corresponding CFC pMDIs. As a result of the similar pharmaceutical performance, it is unnecessary to change the label claim dose of active drug when making the transition from a CFC to an HFA 134a pMDI for salbutamol (Ventolin TM) and fluticasone propionate (FlixotideXM). A seamless transition to non-CFC pMDIs will help to maintain the confidence of patients and healthcare professionals in asthma therapy.

Research paper thumbnail of A metered dose inhaler of salmeterol

Research paper thumbnail of Metered dose inhaler Albuterol

Research paper thumbnail of Dosing Inhibitor for Albuterol

SE DESCRIBE UN INHALADOR DE DOSIS MEDIDA QUE PRESENTA TODAS O PARTE DE SUS SUPERFICIES INTERNAS R... more SE DESCRIBE UN INHALADOR DE DOSIS MEDIDA QUE PRESENTA TODAS O PARTE DE SUS SUPERFICIES INTERNAS RECUBIERTAS CON UNO O MAS POLIMEROS DE FLUOROCARBONO, OPCIONALMENTE EN COMBINACION CON UNO O MAS POLIMEROS NO FLUOROCARBONADOS, PARA LA DISPENSACION DE UNA FORMULACION DE FARMACO DE INHALACION QUE CONTIENE ALBUTEROL O UNA SAL FISIOLOGICAMENTE ACEPTABLE DEL MISMO, Y UN PROPELENTE DE FLUOROCARBONO, OPCIONALMENTE EN COMBINACION CON UNO O MAS AGENTES ACTIVOS FARMACOLOGICAMENTE Y UNO O MAS EXCIPIENTES.

Research paper thumbnail of MDI beclomethasone dipropionate

DESCRIBED A Metered Dose Inhaler HOLDING ALL OR PART OF YOUR INNER surface coated with one or mor... more DESCRIBED A Metered Dose Inhaler HOLDING ALL OR PART OF YOUR INNER surface coated with one or more fluorocarbon polymers, optionally in combination with one or more non-fluorocarbon polymers, for dispensing a drug formulation inhalable COMPRISING beclomethasone dipropionate OR solvate physiologically acceptable thereof, and a fluorocarbon propellant, optionally in combination with one or more pharmacologically AGENTS assets or one or more excipients.