Practical, regulatory and clinical considerations for development of inhalation drug products

Hou, Shuguang; Wu, Jiangyue; Li, Xu; Shu, Hong

doi:10.1016/j.ajps.2015.08.008

Cited by 46 publications

(30 citation statements)

References 49 publications

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“…Ann Transl Med 2017;5(22):448 atm.amegroups.com that aerosols are generated only during inspiration (20).…”

Section: Types Of Nebulisers and Methods Of Nebulisationmentioning

confidence: 99%

“…Qualitative sameness (Q1) implies that the generic product uses the same inactive ingredient as the originator whereas the quantitative sameness (Q2) infers that the concentration of the inactive ingredients in the generic product must be within 5% of those in the originator. The guidance documents have been criticised and challenged by bodies representing the pharmaceutical industry and rather than follow the Q2 requirement, it has been proposed to incorporate a qualityby-design (QbD) approach to study the control space of the excipient concentration for each generic product (20,56,57).…”

Section: Regulatory Perspective Of Inhalation Products By Ema and Fdamentioning

confidence: 99%

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Nebulised antibiotherapy: conventional versus nanotechnology-based approaches, is targeting at a nano scale a difficult subject?

et al. 2017

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Nebulised antibiotics offer great advantages over intravenously administered antibiotics and other conventional antibiotic formulations. However, their use is not widely standardized in the current clinical practice. This is the consequence of large variability in the performance of nebulisers, patient compliance and a deficiency of robust preclinical and clinical data. Nebulised antibiotherapy may play a significant role in future pulmonary drug delivery treatments as it offers the potential to achieve both a high local drug concentration and a lower systemic toxicity. In this review, the physicochemical parameters required for optimal deposition to the lung in addition to the main characteristics of currently available formulations and nebuliser types are discussed. Particular attention will be focused on emerging nanotechnology based approaches which are revolutionizing inhaled therapies used to treat both infections and lung cancer. Promising carriers such as Trojan-Horse microparticles, liposomes, polymeric and lipid nanoparticulate systems have been investigated and proposed as viable options. In order to achieve site-specific targeting and to optimize the PK/PD balance critical nanoscale design parameters such as particle size, morphology, composition, rigidity and surface chemistry architecture must be controlled. Development of novel excipients to manufacture these nanomedicines and assessment of their toxicity is also a keystone and will be discussed in this review.

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“…Ann Transl Med 2017;5(22):448 atm.amegroups.com that aerosols are generated only during inspiration (20).…”

Section: Types Of Nebulisers and Methods Of Nebulisationmentioning

confidence: 99%

Section: Regulatory Perspective Of Inhalation Products By Ema and Fdamentioning

confidence: 99%

Nebulised antibiotherapy: conventional versus nanotechnology-based approaches, is targeting at a nano scale a difficult subject?

et al. 2017

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“…Nebulizers are devices that generate microdroplets from a solution or suspension for pulmonary drug delivery . Nebulization is used in the medical practice to deliver bronchodilators, antibiotics, mucolytic drugs and local anesthetics.…”

Section: Introductionmentioning

confidence: 99%

“…Lung deposition seems to be optimal when droplet diameter is between 2 and 5 μm, whereas larger particles will have a larger deposition in the oropharynx . The droplet size distribution and the drug delivery rate are considered to be the critical quality attributes of nebulized drugs . Ideally, prescriptions for nebulization should include both the drug and the equipment .…”

Section: Introductionmentioning

confidence: 99%

Nebulization as a tool for photosensitizer delivery to the respiratory tract

Kassab

Geralde

Inada

et al. 2018

Journal of Biophotonics

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To this day, any photosensitizers for the photodynamic treatment of pulmonary illnesses have been administered intravenously. There is, however, an intrinsic difficulty in reaching the target cells or bacteria in the respiratory system. Nebulization could overcome distribution problems and alleviate side effects by delivering the photosensitizers directly to the lungs. In this study, we evaluated the viability of three photosensitizers (indocyanine green, the chlorine Photodithazine®, and the porphyrin Photogem®) was evaluated comparatively in a jet nebulizer. Quantitative analysis was performed by looking at the droplet size, extent of nebulization, output over time, and stability of the solutions. All of the tested photosensitizers were found to be adequately nebulized. We also demonstrated the delivery of indocyanine green to the pulmonary tract and its activation with infrared light in a murine model using extracorporeal detection of fluorescence. This was an important step towards clinical implementation of the extracorporeally-illuminated photodynamic inactivation of pneumonia, recently demonstrated in vivo by this research group. This article is protected by copyright. All rights reserved.

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“…The formulation of a drug intended for pulmonary delivery together with an inhaler device constitutes an inhalation product (Hou et al, 2015). The compatibility between the inhalation device and the formulation, comprised of the active pharmaceutical ingredient (API) and the excipients, is essential to efficiently deliver the API to the target site.…”

Section: Formulation and Delivery Of Inhalation Productsmentioning

confidence: 99%

Challenges Associated with the Pulmonary Delivery of Therapeutic Dry Powders for Preclinical Testing

Price

Kunda

Muttil

2019

KONA

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Significant progress has been made over the last half-century in delivering therapeutics by the pulmonary route. Inhaled therapeutics are administered to humans using metered-dose inhalers, nebulizers, or dry powder inhalers, and each device requires a different formulation strategy for the therapeutic to be successfully delivered into the lung. In recent years, there has been a shift to the use of dry powder inhalers due to advantages in the consistency of the dose delivered, ease of administration, and formulation stability. Numerous preclinical studies, involving small and large animals, have evaluated dry powder drugs, vaccines, and immunotherapeutics delivered by the pulmonary route. These studies used different dry powder delivery devices including nose-only, whole-body, and intratracheal administration systems, each of which works with different aerosolization mechanisms. Unfortunately, these delivery platforms usually lead to variable powder deposition in the respiratory tract of animals. In this review, we will discuss obstacles and variables that affect successful pulmonary delivery and uniform powder deposition in the respiratory tract, such as the type of delivery device, dry powder formulation, and the animal model used. We will conclude by outlining factors that enhance the reproducible deposition of dry powders in the respiratory tract of preclinical animal models and identifying knowledge and technology gaps within the field. We will also outline the important factors necessary for successful translation of studies performed in preclinical models to humans.

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Practical, regulatory and clinical considerations for development of inhalation drug products

Cited by 46 publications

References 49 publications

Nebulised antibiotherapy: conventional versus nanotechnology-based approaches, is targeting at a nano scale a difficult subject?

Nebulised antibiotherapy: conventional versus nanotechnology-based approaches, is targeting at a nano scale a difficult subject?

Nebulization as a tool for photosensitizer delivery to the respiratory tract

Challenges Associated with the Pulmonary Delivery of Therapeutic Dry Powders for Preclinical Testing

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