Development and Approval of Inhaled Respiratory Drugs: A US Regulatory Science Perspective

Singh, Gulab; Poochikian, Guirag

doi:10.1007/978-1-4419-9745-6_21

Cited by 5 publications

(4 citation statements)

References 94 publications

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“…This leads to pMDIs which have a variable ratio of fine particle dose to suspension concentration, when formulated in different strengths, using different microcrystal size, or when combined with another drug component . Such lack of dosing proportionality complicates the development of new combination pMDI products, and impedes their clinical evaluation, which requires a comparative clinical testing of the combination inhaler along with each of the respective single component inhalers, administered alone or coadministered sequentially in several dose strengths …”

Section: Introductionmentioning

confidence: 99%

“…19 Such lack of dosing proportionality complicates the development of new combination pMDI products, and impedes their clinical evaluation, which requires a comparative clinical testing of the combination inhaler along with each of the respective single component inhalers, administered alone or coadministered sequentially in several dose strengths. 22 Several approaches have been developed or proposed to improve the colloidal stability in pMDIs. One option is the use of HFA-soluble polymers such as poly(ethylene glycol) or polyvinyl pyrrolidone as suspension stabilizers.…”

Section: ■ Introductionmentioning

confidence: 99%

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Cosuspensions of Microcrystals and Engineered Microparticles for Uniform and Efficient Delivery of Respiratory Therapeutics from Pressurized Metered Dose Inhalers

et al. 2012

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Engineered porous phospholipid microparticles with aerodynamic diameters in the respirable range of 1-2 μm were cosuspended in 1,1,1,2-tetrafluoroethane, a propellant, with microcrystals of glycopyrrolate, formoterol fumarate dihydrate, or Mometasone furoate-three drugs with different solubilities in the propellant, and different physical, chemical, and pharmacological attributes. The drug microcrystals were added individually, in pairs, or all three together to prepare different cosuspensions, contained in a pressurized metered dose inhaler (pMDI). The drug microcrystals irreversibly associated with the porous particles, and the resultant cosuspensions possessed greatly improved suspension stability compared with suspensions of drug microcrystals alone. In general, all cosuspensions showed efficient dose delivery of the drugs, with fine particle fractions of more than 60% for a wide range of doses, including those as low as 300 ng per inhaler actuation. In the cosuspension pMDIs, comparable fine particle fractions were delivered for all tested drugs, whether or not they were emitted from an inhaler containing one, two, or three drugs. We demonstrate that the cosuspension approach solves at least three long-standing problems in the clinical development of pMDI-based products: (1) dose and drug dependent delivery efficiency, (2) inability to formulate dose strengths below 1 μg to fully explore drug efficacy and safety, and (3) combination suspensions delivering a different fine particle fraction than individual drug suspensions.

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Section: Introductionmentioning

confidence: 99%

Section: ■ Introductionmentioning

confidence: 99%

Cosuspensions of Microcrystals and Engineered Microparticles for Uniform and Efficient Delivery of Respiratory Therapeutics from Pressurized Metered Dose Inhalers

et al. 2012

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“…However, till now there is no controlled-release inhalation dosage form approved in the USA. The absence of which may be the result of the untested longterm safety profile of many of the excipients that could be potentially used [116][117][118].…”

Section: Consideration Of Therapeutic Dosage For Controlled Pulmonarymentioning

confidence: 98%

Hydrogels for Controlled Pulmonary Delivery

2013

Ther. Deliv.

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A significant number of research articles have focused on pulmonary delivery as an alternative administration route owing to no first-pass metabolism, low protease activity, thin epithelium barrier and large surface area in the lung system. Controlled release in the pulmonary delivery system further reduces loading dose, frequency of dosing and systemic side effects, and also increases duration of action and patient compliance. Compared with other microparticles used in controlled-release pulmonary administration, hydrogels (3D polymeric matrix networks) have recently been investigated due to their swelling and mucoadhesive properties that could help bypass pulmonary delivery barriers. This review introduces controlled-release drug delivery to the lung, followed by a summary of currently available approaches for controlled-release pulmonary drug delivery. Lastly, the origin, advantages, detailed applications and concerns of hydrogels in pulmonary delivery are discussed.

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“…However, a tighter control on particle size of API is desirable in sublingual drug products to maintain a reproducible quality and performance of the drug product in view of the limited window of dissolution and absorption To address this critical difference, various researchers have proposed approaches to test disintegration and dissolution of sublingual tablets. Some of these approaches make use of thephysiological conditions of the oral cavity as a guide in testing disintegration 75 and dissolution of sublingual tablets.…”

Section: Most Of These Tests Are Universal Quality Evaluations Of Conmentioning

confidence: 99%

Sublingual Tablets and the Benefits of the Sublingual Route of Administration

Khan

Kingsley

Caroline

2017

Journal of Pharmaceutical Research

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Sublingual tablets Purpose: Sublingual drug delivery can be an alternative and better route when compared to oral drug delivery as sublingually administered dosage forms bypass hepatic metabolism. A rapid onset of pharmacological effect is often desired for some drugs, especially those used in the treatment of acute disorders. Sublingual tablets disintegrate rapidly and the small amount of saliva present is usually sufficient for achieving disintegration of the dosage form coupled with better dissolution and increased bioavailability. Approach: Published articles from PubMed and other standard sources were utilized to review and compile an overview of sublingual tablets and the benefits of the sublingual route of administration. Findings: Sublingual tablets were found to have better characteristics when compared to conventional dosage forms. Sublingually administered tablets achieved better bioavailability, rapid onset of action and better dissolution properties due to fast disintegration. The addition of super-disintegrants facilitated rapid disintegration and this approach can be used to treat acute disorders or emergency conditions. Conclusion: Sublingual tablets or any sublingual dosage form can be used to achieve a rapid onset of action, better patient compliance and increased bioavailability. The sublingual route of administration can be used for drugs which undergo extensive first pass metabolism or degradation in the GIT. Drugs administered sublingually tend to have better bioavailability which correlates to dose reduction when compared to conventional oral tablets.

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Development and Approval of Inhaled Respiratory Drugs: A US Regulatory Science Perspective

Cited by 5 publications

References 94 publications

Cosuspensions of Microcrystals and Engineered Microparticles for Uniform and Efficient Delivery of Respiratory Therapeutics from Pressurized Metered Dose Inhalers

Cosuspensions of Microcrystals and Engineered Microparticles for Uniform and Efficient Delivery of Respiratory Therapeutics from Pressurized Metered Dose Inhalers

Hydrogels for Controlled Pulmonary Delivery

Sublingual Tablets and the Benefits of the Sublingual Route of Administration

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