A New Approach to the Safety Assessment of Pharmaceutical Excipients

Steinberg, Marshall; Borzelleca, Joseph F.; Enters, E.K.; Kinoshita, Florence K.; Loper, Alice E.; Mitchell, D.B.; Tamulinas, C.B.; Weiner, Myra L.

doi:10.1006/rtph.1996.0120

Cited by 45 publications

(17 citation statements)

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“…These prerequisites require a sophisticated choice of excipients and formulation strategies. There are only few excipients which are registered for the use in the respiratory tract like sugars, some solvents and a few surface active substances and the will to register new substances as excipients is very restricted due to the high costs of the toxicity studies demanded by the authorities (Steinberg et al, 1996;DeGeorge et al, 1997;Baldrick, 2000). Due to the very limited repertory of excipients for the respiratory administration route, it is extremely difficult to formulate modern drugs or to create functional formulations with mucoadhesiveness or sustained release.…”

Section: Introductionmentioning

confidence: 99%

The MTT assay as tool to evaluate and compare excipient toxicity in vitro on respiratory epithelial cells

Scherließ

2011

International Journal of Pharmaceutics

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Section: Introductionmentioning

confidence: 99%

The MTT assay as tool to evaluate and compare excipient toxicity in vitro on respiratory epithelial cells

Scherließ

2011

International Journal of Pharmaceutics

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“…A vaccine formulation for the lung will be quite restricted in the choice of excipients, as the list of substances already approved for use in pulmonary dosage forms is limited. Apart from lactose, which is used as carrier in many dry powder formulations in the treatment of asthma or COPD, mannitol, glucose and sorbitol as well as some surfactants, some solvents and a limited number of polymers could be used without the need for registration of a novel excipient including all toxicity and safety tests [102,103]. Similar to a nasal vaccine NiM formulation, the matrix excipient needs to be capable for rapid dissolution in the lung mucus or the surfactant fluid in order to release the vaccine carrier [103].…”

Section: Respiratory Vaccine Formulationsmentioning

confidence: 99%

“…Apart from lactose, which is used as carrier in many dry powder formulations in the treatment of asthma or COPD, mannitol, glucose and sorbitol as well as some surfactants, some solvents and a limited number of polymers could be used without the need for registration of a novel excipient including all toxicity and safety tests [102,103]. Similar to a nasal vaccine NiM formulation, the matrix excipient needs to be capable for rapid dissolution in the lung mucus or the surfactant fluid in order to release the vaccine carrier [103]. If the formulation has a sufficient FPF for efficient lung delivery, it should not cause irritancy as this effect is normally caused by larger particles impacting in the oropharynx.…”

Section: Respiratory Vaccine Formulationsmentioning

confidence: 99%

Mucosal Vaccination via the Respiratory Tract

Hellfritzsch

Scherließ

2019

Pharmaceutics

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Vaccine delivery via mucosal surfaces is an interesting alternative to parenteral vaccine administration, as it avoids the use of a needle and syringe. Mucosal vaccine administration also targets the mucosal immune system, which is the largest lymphoid tissue in the human body. The mucosal immune response involves systemic, antigen-specific humoral and cellular immune response in addition to a local response which is characterised by a predominantly cytotoxic T cell response in combination with secreted IgA. This antibody facilitates pathogen recognition and deletion prior to entrance into the body. Hence, administration via the respiratory mucosa can be favoured for all pathogens which use the respiratory tract as entry to the body, such as influenza and for all diseases directly affecting the respiratory tract such as pneumonia. Additionally, the different mucosal tissues of the human body are interconnected via the so-called “common mucosal immune system”, which allows induction of an antigen-specific immune response in distant mucosal sites. Finally, mucosal administration is also interesting in the area of therapeutic vaccination, in which a predominant cellular immune response is required, as this can efficiently be induced by this route of delivery. The review gives an introduction to respiratory vaccination, formulation approaches and application strategies.

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“…As compounds become more challenging to formulate, new excipients are needed to enable the delivery, manufacture and development of these compounds. Conventional excipients have been replaced with sophisticated compounds that fulfill multifunctional roles in modern pharmaceutical dosage forms such as improvement of the stability and bioavailability of the active ingredient, enhancement of patient acceptability and performance of technological functions that ensure ease of manufacture (Steinberg et al, 1996 andPifferi et al, 2003).…”

Section: Introductionmentioning

confidence: 99%

Modified Excipients in Novel Drug Delivery: Need of the Day

Kanojia

Kaur

Nagpal

et al. 2013

JPTRM

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Drug products not only contain "actives" that confer the intended therapeutic benefits such as pain relief or act on particular part of the body, but contain other materials that are also "functional" with respect to the drug product. These are known as excipients and specific functionality which they confer to a particular product is independent upon the process used to add the excipient to the formulation and its exact location within the final dosage form. Introduction of novel drug delivery systems and new drug moieties lead to the need for new excipients with varied characteristics. Development of new excipient entities and their evaluation is a costly procedure; modification of existing excipients is very easy, more economical and less time consuming. The development of excipients that are capable of fulfilling multifunctional roles such as enhancing drug bioavailability and drug stability as well as controlling the release of the drug according to the therapeutic needs is one of the most important prerequisites for further progress in the design of novel drug delivery systems. The main focus of this article is on synthetic novel excipients that perform multiple functions in pharmaceutical formulations.

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A New Approach to the Safety Assessment of Pharmaceutical Excipients

Cited by 45 publications

References 0 publications

The MTT assay as tool to evaluate and compare excipient toxicity in vitro on respiratory epithelial cells

The MTT assay as tool to evaluate and compare excipient toxicity in vitro on respiratory epithelial cells

Mucosal Vaccination via the Respiratory Tract

Modified Excipients in Novel Drug Delivery: Need of the Day

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