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https://www.readbyqxmd.com/read/28905245/identification-of-polymorphic-forms-of-active-pharmaceutical-ingredient-in-low-concentration-dry-powder-formulations-by-synchrotron-x-ray-powder-diffraction
#1
Kenji Egusa, Fumiaki Okazaki, Joerg Schiewe, Ulrike Werthmann, Markus Wolkenhauer
BACKGROUND: The identification of different (pseudo) polymorphs of an active pharmaceutical ingredient in dry powder formulations is of importance during development and entire product lifecycle, e.g., quality control. Whereas determination of polymorphic differences of pure substances is rather easy, in dry powder formulations, it is generally difficult and the difficulties increase particularly, if the substance of interest is present only in low concentrations in the formulation. Such a formulation is SpirivaR inhalation powder (Boehringer Ingelheim), which contains only 0...
September 13, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28903066/development-of-fine-solid-crystal-suspension-with-enhanced-solubility-stability-and-aerosolization-performance-for-dry-powder-inhalation
#2
Ling Lin, Guilan Quan, Tingting Peng, Zhengwei Huang, Vikramjeet Singh, Ming Lu, Chuanbin Wu
Dry powder for inhalation (DPI) is an attractive approach for the treatment of local lung diseases. However, the application of drugs with poor water solubility is often limited due to the dissolution obstacles in the fluid layer of the lung lining. In this study, fine solid-crystal suspension (FSCS) was proposed as a solvent-free method to improve the solubility of a drug with poor solubility (itraconazole) and achieve high deposition efficiency simultaneously. The FSCS, in which the crystalline drug particle was highly dispersed in the crystalline excipient, was initially prepared as drug-excipient extrudate by hot melt extrusion, followed by jet milling into fine particles...
September 10, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28891722/requirements-strengths-and-weaknesses-of-inhaler-devices-for-copd-patients-from-the-expert-prescribers-point-of-view-results-of-the-epoca-delphi-consensus
#3
Francisco García-Río, Juan J Soler-Cataluña, Bernardino Alcazar, José L Viejo, Marc Miravitlles
The study aimed to assess the preferences of expert physicians about the requirements for inhalation devices for patients with chronic obstructive pulmonary disease (COPD) and to identify the most relevant advantages and disadvantages to their prescription. In a two-round Delphi survey, 96 Spanish COPD-expert pulmonologists completed an internet-based questionnaire to evaluate the degree of importance of the characteristics of the inhaler devices in their choice for COPD. The requirements needed for use in COPD were that the device permits a high pulmonary deposit of the drug, allowed its dispensation at low inspiratory flows, did not require hand-mouth coordination, generated an exact and reproducible dose, its operation was easy to teach, provided the perception of a correct inhalation, had an intuitive use mechanism and security mechanisms to prevent overdosing and generates a reduced oropharyngeal deposit (very good consensus)...
September 11, 2017: COPD
https://www.readbyqxmd.com/read/28887232/dry-powder-inhalers-an-overview-of-the-in-vitro-dissolution-methodologies-and-their-correlation-with-the-biopharmaceutical-aspects-of-the-drug-products
#4
Sitaram Velaga, Jelena Djuris, Sandra Cvijic, Stavroula Rozou, Paola Russo, Gaia Colombo, Alessandra Rossi
In vitro dissolution testing is routinely used in the development of pharmaceutical products. Whilst the dissolution testing methods are well established and standardized for oral dosage forms, i.e. tablets and capsules, there are no pharmacopoeia methods or regulatory requirements for testing the dissolution of orally inhaled powders. Despite this, a wide variety of dissolution testing methods for orally inhaled powders has been developed and their bio-relevance has been evaluated. The review provides an overview of the in vitro dissolution methodologies for dry inhalation products, with particular emphasis on dry powder inhaler, where the dissolution behavior of the respirable particles can have a role on duration and absorption of the drug...
September 5, 2017: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28887061/advances-in-audio-based-systems-to-monitor-patient-adherence-and-inhaler-drug-delivery
#5
REVIEW
Terence E Taylor, Yaniv Zigel, Céline De Looze, Imran Sulaiman, Richard W Costello, Richard B Reilly
Hundreds of millions of people suffer from asthma and chronic obstructive pulmonary disease (COPD) worldwide. Current medications to control these chronic respiratory diseases can be administered using inhaler devices, such as the pressurized metered dose inhaler (pMDI) and dry powder inhaler (DPI). Providing that they are used as prescribed, inhalers can improve patients' clinical outcomes and quality of life. Poor patient inhaler adherence (both time of use and user technique) is, however, a major clinical concern and is associated with poor disease control, increased hospital admissions and increased mortality rates, particularly in low-middle income countries...
September 5, 2017: Chest
https://www.readbyqxmd.com/read/28884969/evaluation-of-bioequivalence-between-the-new-procaterol-hydrochloride-hydrate-dry-powder-inhaler-and-the-approved-dry-powder-inhaler-in-patients-with-asthma-in-a-randomized-double-blind-double-dummy-crossover-comparison-study-a-phase%C3%A2-3-study
#6
Ryo Shirai, Yuki Suzaki, Kyoko Sato, Yuko Takeuchi, Issei Tokimatsu, Nobuyuki Koga, Junichi Kadota, Kyoichi Ohashi
Procaterol hydrochloride hydrate (procaterol) is a β2 -adrenergic receptor agonist that induces a strong bronchodilatory effect. The procaterol dry powder inhaler (DPI) has been frequently used in patients with bronchial asthma or chronic obstructive pulmonary disease. We evaluated the bioequivalence and safety between the new procaterol DPI (new DPI) and the approved procaterol DPI (approved DPI). This study was a randomized, double-blind, double-dummy, crossover comparison to evaluate the pharmacodynamic equivalence of the new DPI and the approved DPI in patients with bronchial asthma...
September 8, 2017: Clinical Pharmacology in Drug Development
https://www.readbyqxmd.com/read/28883722/activate-the-effect-of-aclidinium-formoterol-on-hyperinflation-exercise-capacity-and-physical-activity-in-patients-with-copd
#7
Henrik Watz, Thierry Troosters, Kai M Beeh, Judith Garcia-Aymerich, Pierluigi Paggiaro, Eduard Molins, Massimo Notari, Antonio Zapata, Diana Jarreta, Esther Garcia Gil
The Phase IV, 8-week, randomized, double-blind, placebo-controlled ACTIVATE study (NCT02424344) evaluated the effect of aclidinium/formoterol (AB/FF) 400/12 μg twice daily on lung hyperinflation, exercise capacity, and physical activity in patients with moderate-to-severe COPD. Patients received AB/FF (n=134) or placebo (n=133) (1:1) via the Genuair™/Pressair(®) dry powder inhaler for 8 weeks. From Weeks 5 to 8, all patients participated in behavioral intervention (BI; daily messages providing step goals)...
2017: International Journal of Chronic Obstructive Pulmonary Disease
https://www.readbyqxmd.com/read/28874611/how-should-aerosols-be-delivered-during-invasive-mechanical-ventilation
#8
Rajiv Dhand
The delivery of aerosols to mechanically ventilated patients presents unique challenges and differs from inhaled drug delivery in spontaneously breathing patients in several respects. Successful aerosol delivery during invasive mechanical ventilation requires careful consideration of a host of factors that influence the amount of drug inhaled by the patient. Pressurized metered-dose inhalers and nebulizers (jet, ultrasonic, and vibrating mesh) are the most commonly used aerosol delivery devices in these patients, although other delivery devices, such as dry powder inhalers, soft mist inhalers, and intratracheal nebulizing catheters, could also be adapted for in-line use...
September 5, 2017: Respiratory Care
https://www.readbyqxmd.com/read/28864391/particle-interactions-of-fluticasone-propionate-and-salmeterol-xinafoate-detected-with-single-particle-aerosol-mass-spectrometry-spams
#9
Martin W Jetzer, Bradley D Morrical, David P Fergenson, Georgios Imanidis
Particle co-associations between the active pharmaceutical ingredients fluticasone propionate and salmeterol xinafoate were examined in dry powder inhaled (DPI) and metered dose inhaled (MDI) combination products. Single Particle Aerosol Mass Spectrometry was used to investigate the particle interactions in Advair Diskus(®) (500/50 mcg) and Seretide(®) (125/25 mcg). A simple rules tree was used to identify each compound, either alone or co-associated at the level of the individual particle, using unique marker peaks in the mass spectra for the identification of each drug...
August 31, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28860739/the-comparative-effectiveness-of-initiating-fluticasone-salmeterol-combination-therapy-via-pmdi-versus-dpi-in-reducing-exacerbations-and-treatment-escalation-in-copd-a-uk-database-study
#10
Rupert Jones, Jessica Martin, Vicky Thomas, Derek Skinner, Jonathan Marshall, Martina Stagno d'Alcontres, David Price
Chronic obstructive pulmonary disease (COPD), a complex progressive disease, is currently the third leading cause of death worldwide. One recommended treatment option is fixed-dose combination therapy of an inhaled corticosteroid (ICS)/long-acting β-agonist. Clinical trials suggest pressurized metered-dose inhalers (pMDIs) and dry powder inhalers (DPIs) show similar efficacy and safety profiles in COPD. Real-world observational studies have shown that combination therapy has significantly greater odds of achieving asthma control when delivered via pMDIs...
2017: International Journal of Chronic Obstructive Pulmonary Disease
https://www.readbyqxmd.com/read/28842308/void-forming-index-a-new-parameter-for-detecting-microstructural-transformation-caused-by-powder-agglomeration
#11
Sunao Maruyama, Etsuo Yonemochi, Susumu Hasegawa, Satoshi Suzuki, Hidemi Minami
As powder agglomeration during storage causes a decrease in the performance of dry powder inhalers (DPIs), it is important to understand the properties of powder agglomeration in developing DPIs. Generally, powder agglomeration is caused by capillary force and crystalline transformation in conditions of higher humidity. It is, however, difficult to correlate crystalline transformation and powder agglomeration, especially when the crystalline transformation is limited. In this study, we focused on the application of inverse gas chromatography (iGC) to detect powder agglomeration directly...
August 24, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28840529/co-spray-dried-mannitol-poly-amidoamine-doxorubicin-dry-powder-inhaler-formulations-for-lung-adenocarcinoma-morphology-in-vitro-evaluation-and-aerodynamic-performance
#12
Qian Zhong
nhaled chemotherapeutics have emerged as a promising regimen to combat lung cancer as they maximize local drug concentration while significantly reduce systemic exposure. However, the poor lung/systemic safety profiles and lack of clinically efficient formulations restrict the applicability of inhaled chemotherapeutics. This work developed a dry-powder inhaler (DPI) formulation that dispersed a pH-responsive poly(amidoamine) dendrimer-doxorubicin conjugate (G4-12DOX) into mannitol microparticles. The dendrimer conjugate only releases cytotoxic agents in response to intracellular pH drop, leading to reduced systemic and local toxicity...
August 23, 2017: AAPS PharmSciTech
https://www.readbyqxmd.com/read/28831840/crystal-engineering-of-lactose-using-electrospray-technology-carrier-for-pulmonary-drug-delivery
#13
Sharvil Patil, Abhijeet Mahadik, Pradeep Nalawade, Priyesh More
CONTEXT: Dry powder inhalers (DPIs) consisting of a powder mixture containing coarse carrier particles (generally lactose) and micronized drug particles are used for lung drug delivery. The effective drug delivery to the lungs depends on size and shape of carrier particles. Thus various methods have been proposed for engineering lactose particles to enhance drug delivery to lungs. OBJECTIVE: The objective of current work was to assess suitability of electrospray technology towards crystal engineering of lactose...
August 23, 2017: Drug Development and Industrial Pharmacy
https://www.readbyqxmd.com/read/28826725/dry-powder-aerosols-to-co-deliver-antibiotics-and-nutrient-dispersion-compounds-for-enhanced-bacterial-biofilm-eradication
#14
S Sommerfeld Ross, S Gharse, L Sanchez, J Fiegel
The purpose of this study was to formulate a dry powder for inhalation containing a combination treatment for eradication of Pseudomonas aeruginosa bacterial biofilms. Dry powders containing an antibiotic (ciprofloxacin hydrochloride, CH) and nutrient dispersion compound (glutamic acid, GA) at a ratio determined to eliminate the biofilms were generated by spray drying. Leucine was added to the spray dried formulation to aid powder flowability. A central composite design of experiments was performed to determine the effects of solution and processing parameters on powder yield and aerodynamic properties...
October 5, 2017: International Journal of Pharmaceutics
https://www.readbyqxmd.com/read/28821437/particle-sizing-of-pharmaceutical-aerosols-via-direct-imaging-of-particle-settling-velocities
#15
Rami Fishler, Frank Verhoeven, Wilbur de Kruijf, Josué Sznitman
We present a novel method for characterizing in near real-time the aerodynamic particle size distributions from pharmaceutical inhalers. The proposed method is based on direct imaging of airborne particles followed by a particle-by-particle measurement of settling velocities using image analysis and particle tracking algorithms. Due to the simplicity of the principle of operation, this method has the potential of circumventing potential biases of current real-time particle analyzers (e.g. Time of Flight analysis), while offering a cost effective solution...
August 16, 2017: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28809447/pulmonary-delivery-of-tea-tree-oil-%C3%AE-cyclodextrin-inclusion-complexes-for-the-treatment-of-fungal-and-bacterial-pneumonia
#16
Miao Li, Lifei Zhu, Tongtong Zhang, Boming Liu, Lina Du, Yiguang Jin
OBJECTIVES: Bacterial pneumonia is a common cause of death worldwide. Tea tree oil (TTO) is a potent antimicrobial natural product, which is formulated in dry powder inhalers (DPIs) for the treatment of fungal and bacterial pneumonia. METHODS: Tea tree oil-β-cyclodextrin inclusion complexes (TTO-β-CD) were prepared and characterized. Aerodynamic properties of TTO-β-CD powders were measured. The rat models of fungal (Candida albicans) and bacterial (Acinetobacter baumannii) pneumonia were prepared...
August 15, 2017: Journal of Pharmacy and Pharmacology
https://www.readbyqxmd.com/read/28807905/pulmonary-pharmacokinetics-of-colistin-following-administration-of-dry-powder-aerosols-in-rats
#17
Yu-Wei Lin, Qi Tony Zhou, Yang Hu, Nikolas J Onufrak, Siping Sun, Jiping Wang, Alan Forrest, Hak-Kim Chan, Jian Li
Colistin has been administered via nebulization for the treatment of respiratory tract infections. Recently, dry powder inhalation (DPI) has attracted increasing attention. The current study aimed to investigate the pharmacokinetics (PK) of colistin in epithelial lining fluid (ELF) and plasma following DPI and intravenous (IV) administration in healthy Sprague-Dawley rats. Rats were given colistin as DPI intratracheally (0.66 and 1.32 mg base/kg) or IV injection (0.66 mg base/kg). Histopathological examination of lung tissue was performed at 24 h...
August 14, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28800360/prerequisites-for-a-dry-powder-inhaler-for-children-with-cystic-fibrosis
#18
Anne J Lexmond, Paul Hagedoorn, Henderik W Frijlink, Bart L Rottier, Anne H de Boer
Correct inhalation technique is essential for effective use of dry powder inhalers (DPIs), as their effectiveness largely depends on the patient's inhalation manoeuvre. Children are an especially challenging target population for DPI development due to the large variability in understanding and inspiratory capacities. We previously performed a study in which we determined the prerequisites for a paediatric DPI in a mostly healthy paediatric population, for which we used an empty test inhaler with variable internal airflow resistance and mouthpiece...
2017: PloS One
https://www.readbyqxmd.com/read/28799097/predicting-pulmonary-pharmacokinetics-from-in-vitro-properties-of-dry-powder-inhalers
#19
Sharvari Bhagwat, Uta Schilling, Mong-Jen Chen, Xiangyin Wei, Renishkumar Delvadia, Mohammad Absar, Bhawana Saluja, Günther Hochhaus
PURPOSE: The ability of two semi-mechanistic simulation approaches to predict the systemic pharmacokinetics (PK) of inhaled corticosteroids (ICSs) delivered via dry powder inhalers (DPIs) was assessed for mometasone furoate, budesonide and fluticasone propionate. METHODS: Both approaches derived the total lung doses and the central to peripheral lung deposition ratios from clinically relevant cascade impactor studies, but differed in the way the pulmonary absorption rate was derived...
August 10, 2017: Pharmaceutical Research
https://www.readbyqxmd.com/read/28780275/inhalable-sirna-loaded-nano-embedded-microparticles-engineered-using-microfluidics-and-spray-drying
#20
Monica Agnoletti, Adam Bohr, Kaushik Thanki, Feng Wan, Xianghui Zeng, Johan Peter Boetker, Mingshi Yang, Camilla Foged
Medicines based on small interfering RNA (siRNA) are promising for the treatment of a number of lung diseases. However, efficient delivery systems and design of stable dosage forms are required for inhalation therapy, as well as cost-effective methods for manufacturing of the final product. In this study, a 3D-printed micromixer was used for preparation of siRNA-dendrimer nanocomplexes, which were subsequently processed into microparticle-based dry powders for inhalation using spray drying. By applying the disposable micromixer, nanocomplexes were prepared of an average hydrodynamic diameter comparable to that of nanocomplexes prepared by manual mixing, but with narrower size distribution and low batch-to-batch variation...
August 2, 2017: European Journal of Pharmaceutics and Biopharmaceutics
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