scholarly journals A review of the in vitro and in vivo valved holding chamber (VHC) literature with a focus on the AeroChamber Plus Flow-Vu Anti-static VHC

2018 ◽  
Vol 12 ◽  
pp. 175346581775134 ◽  
Author(s):  
Sanjeeva Dissanayake ◽  
Jason Suggett
Keyword(s):  
Small Volume ◽  
Metered Dose Inhalers ◽  
Drug Deposition ◽  
Aerosol Performance ◽  
Regulatory Guidelines ◽  
Metered Dose ◽  
Vulnerable Patient ◽  
Patient Groups

Valved holding chambers (VHCs) reduce the need for inhalation-actuation coordination with pressurized metered dose inhalers (pMDIs), reduce oropharyngeal drug deposition and may improve lung deposition and clinical outcomes compared to pMDIs used alone. While VHCs are thus widely advocated for use in vulnerable patient groups within clinical and regulatory guidelines, there is less consensus as to whether the performance differences between different VHCs have clinical implications. This review evaluates the VHC literature, in particular the data pertaining to large- versus small-volume chambers, aerosol performance with a VHC adjunct versus a pMDI alone, charge dissipative/conducting versus non-conducting VHCs, and facemasks, to ascertain whether potentially meaningful differences between VHCs exist. Inconsistencies in the literature are examined and explained, and relationships between in vitro and in vivo data are discussed. A particular focus of this review is the AeroChamber Plus® Flow-Vu® Anti-static VHC, the most recent iteration of the AeroChamber VHC family.

An overview of the toxicology of HFA-134a (1,1,1,2-tetrafluoroethane)

1995 ◽  
Vol 14 (9) ◽  
pp. 715-720 ◽  
Author(s):  
DJ Alexander ◽  
SE Libretto
Keyword(s):  
Research And Development ◽  
Cell Cultures ◽  
In Vitro Studies ◽  
In Vivo Studies ◽  
Metered Dose Inhalers ◽  
Safe Alternative ◽  
Local Tolerance ◽  
Metered Dose

1 This paper reviews the results of preclinical toxicology studies on HFA-134a carried out by Glaxo Research and Development Ltd. 2 A comprehensive range of studies was conducted in ani mal models suitable for the type of investigation. 3 The inhalation route of administration was used in all in vivo studies (with the exception of local tolerance and sensitisation studies) as patients will be exposed only to vapour during actuation of metered-dose inhalers. Cell cultures used for in vitro studies were also exposed to the vapour. 4 There was no mortality of rodents or dogs at extremely high vapour concentrations (81%v/v). 5 HFA-134a was considered not to be toxic or oncogenic and to provide a safe alternative to chlorofluorocarbons for use in pharmaceutical metered-dose inhalers.

scholarly journals Human Oligodendrocytes and Myelin In Vitro to Evaluate Developmental Neurotoxicity

2021 ◽  
Vol 22 (15) ◽  
pp. 7929
Author(s):  
Megan Chesnut ◽  
Thomas Hartung ◽  
Helena Hogberg ◽  
David Pamies
Keyword(s):  
Large Scale ◽  
In Vitro Models ◽  
Environmental Chemicals ◽  
Developmental Neurotoxicity ◽  
In Vivo Studies ◽  
Regulatory Guidelines ◽  
In Vitro Systems ◽  
Human Oligodendrocytes

Neurodevelopment is uniquely sensitive to toxic insults and there are concerns that environmental chemicals are contributing to widespread subclinical developmental neurotoxicity (DNT). Increased DNT evaluation is needed due to the lack of such information for most chemicals in common use, but in vivo studies recommended in regulatory guidelines are not practical for the large-scale screening of potential DNT chemicals. It is widely acknowledged that developmental neurotoxicity is a consequence of disruptions to basic processes in neurodevelopment and that testing strategies using human cell-based in vitro systems that mimic these processes could aid in prioritizing chemicals with DNT potential. Myelination is a fundamental process in neurodevelopment that should be included in a DNT testing strategy, but there are very few in vitro models of myelination. Thus, there is a need to establish an in vitro myelination assay for DNT. Here, we summarize the routes of myelin toxicity and the known models to study this particular endpoint.

scholarly journals ICH Guideline for Biopharmaceutics Classification System-Based Biowaiver (M9): Toward Harmonization in Latin American Countries

Pharmaceutics ◽  
2021 ◽  
Vol 13 (3) ◽  
pp. 363
Author(s):  
Claudia Miranda ◽  
Alexis Aceituno ◽  
Mirna Fernández ◽  
Gustavo Mendes ◽  
Yanina Rodríguez ◽  
...  
Keyword(s):  
Latin American ◽  
Classification System ◽  
Biopharmaceutics Classification System ◽  
In Vitro Dissolution ◽  
Ich Guidelines ◽  
Latin American Region ◽  
Regulatory Guidelines ◽  
Biopharmaceutics Classification

The biopharmaceutical classification system (BCS) is a very important tool to replace the traditional in vivo bioequivalence studies with in vitro dissolution assays during multisource product development. This paper compares the most recent harmonized guideline for biowaivers based on the biopharmaceutics classification system and the BCS regulatory guidelines in Latin America and analyzes the current BCS regulatory requirements and the perspective of the harmonization in the region to develop safe and effective multisource products. Differences and similarities between the official and publicly available BCS guidelines of several Latin American regulatory authorities and the new ICH harmonization guideline were identified and compared. Only Chile, Brazil, Colombia, and Argentina have a more comprehensive BCS guideline, which includes solubility, permeability, and dissolution requirements. Although their regulatory documents have many similarities with the ICH guidelines, there are still major differences in their interpretation and application. This situation is an obstacle to the successful development of safe and effective multisource products in the Latin American region, not only to improve their access to patients at a reasonable cost, but also to develop BCS biowaiver studies that fulfill the quality standards of regulators in developed and emerging markets.

Development of nanomedicines and nano-similars: recent advances in regulatory landscape

2021 ◽  
Vol 27 ◽  
Author(s):  
Rishi Paliwal ◽  
Pramod Kumar ◽  
Akash Chaurasiya ◽  
Rameshroo Kenwat ◽  
Sumeet Katke ◽  
...  
Keyword(s):  
Drug Release ◽  
Pharmaceutical Products ◽  
Regulatory Agencies ◽  
Next Generation ◽  
Similar Drug ◽  
Regulatory Guidelines ◽  
The Moment ◽  
Regulatory Landscape

Background: Nanopharmaceuticals serve as emerging forms of modern medicines which include nanomedicines, nanosimilars, nanotheranostics, nanodevices and many more. In last two decades, a large number of nano-based products has reached to the market and are being used clinically. Objectives: Unlike, conventional pharmaceutical products, nanopharmaceuticals behave differently both in vitro and in vivo and therefore, development of their generic versions needs special attention to replicate the similar drug release pattern leading to the identical therapeutic outcome. Further, drug-device combinations and 3D products are latest advancements in precise medicine delivery and development. Methods: The regulatory guidelines for these products are being framed at many stages by various regulatory agencies like USFDA/EMA and still are in infancy at the moment if we look at wider prospective and applications of nanomedicine. Results: For a formulation scientist, it is much needed that well-explained and directive guidelines should be available before leading to the development of the generic versions of these nano-cargos. Conclusion: Here, in this review, we have summarized the silent features of the regulatory perspectives related to the nanotechnology based next generation therapeutics and diagnostics.

scholarly journals NANO-VESICLES OF SALBUTAMOL SULPHATE IN METERED DOSE INHALERS: FORMULATION, CHARACTERIZATION AND IN VITRO EVALUATION

2017 ◽  
Vol 9 (6) ◽  
pp. 100 ◽  
Author(s):  
Mona G. Arafa ◽  
Bassam M. Ayoub
Keyword(s):  
In Vitro Release ◽  
Pulmonary Delivery ◽  
Entrapment Efficiency ◽  
Reversed Phase ◽  
Molar Ratio ◽  
Metered Dose Inhalers ◽  
Salbutamol Sulphate ◽  
Novel Approach ◽  
Metered Dose

Objective: The present work was aimed to prepare niosomes entrapping salbutamol sulphate (SS) using reversed phase evaporation method (REV).Methods: Niosomes were prepared by mixing span 60 and cholesterol in 1:1 molar ratio in chloroform, SS in water was then added to organic phase to form niosomal SS. Formulations after evaporation of chloroform, freeze centrifuged then lyophilized, were evaluated for particles size, polydispersity index (Pdi), zeta-potential, morphology, entrapment efficiency (EE%) and in vitro release. For pulmonary delivery; metered dose inhalers (MDI) were prepared by suspending SS niosomes equivalent to 20 mg SS in hydrofluoroalkane (HFA). The metered valve was investigated for leakage rate, the total number of puffs/canister, weight/puff, dose uniformity and particle size.Results: The results showed spherical niosomes with 400-451 nm particles that entrapped 66.19% of SS. 76.54±0.132% SS release from niosomes that showed a controlled release profile for 8h. The leakage test was not exceeding 4 mg/3 d, the number of puffs were up to 200puffs/canister, the dose delivered/puff was 0.1 mg and 0.64-4.51μm niosomal aerosol.Conclusion: The results indicate an encouraging strategy to formulate a controlled drug delivery by entrapping (SS) in niosomes which could be packaged into (MDI) that met the requirements of (USP) aerosols guidelines which offering a novel approach to respiratory delivery.

A sensitive HPLC-FL method to simultaneously determine febuxostat and diclofenac in rat plasma: assessment of metabolic drug interactions in vitro and in vivo

2020 ◽  
Vol 12 (16) ◽  
pp. 2166-2175 ◽  
Author(s):  
Dong-Gyun Han ◽  
Kyu-Sang Kim ◽  
Seong-Wook Seo ◽  
Young Mee Baek ◽  
Yunjin Jung ◽  
...  
Keyword(s):  
Sample Preparation ◽  
Drug Interactions ◽  
Simultaneous Determination ◽  
Small Volume ◽  
Rat Plasma ◽  
Metabolic Drug ◽  
Simple Sample Preparation

We developed a sensitive, simple and validated HPLC-FL method for simultaneous determination of FEB and DIC in rat plasma. The method requires a relatively small volume of sample, has simple sample preparation and excellent sensitivity.

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