Gamma scintigraphy for testing bioequivalence: A case study on two cromolyn sodium nasal spray preparations

Al-Ghananeem, Abeer M.; Sandefer, Erik P.; Döll, W; Page, Richard C.; Chang, Yunik; Digenis, George A.

doi:10.1016/j.ijpharm.2008.01.040

Cited by 25 publications

(14 citation statements)

References 28 publications

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“…In fact, the 'human factor' is often ignored in studies assessing nasal in vivo deposition and in Phase 1 trials. Even results obtained after spray delivery by an assistant may not reflect the real-life situation of suffering patients [23,104,105]. In fact, in a combined PK and gamma deposition study where insulin was self-administered with a traditional spray pump, deposition was strictly on the anterior nonciliated mucosa in five out of six subjects and with no sign of systemic insulin absorption [105].…”

Section: Spay Pumps Drops and Syringes With Tubesmentioning

confidence: 99%

The Nasal Approach to Delivering Treatment for Brain Diseases: An Anatomic, Physiologic, and Delivery Technology Overview

Djupesland

Messina

Mahmoud

2014

Therapeutic Delivery

238

154

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The intricate pathophysiology of brain disorders, difficult access to the brain, and the complexity and high risks and costs of drug development represent major hurdles for improving therapies. Nose-to-brain drug transport offers an attractive alternative or addition to formulation-only strategies attempting to enhance drug penetration into the CNS. Although still a matter of controversy, many studies in animals claim direct nose-to-brain transport along the olfactory and trigeminal nerves, circumventing the traditional barriers to CNS entry. Some clinical trials in man also suggest nose-to-brain drug delivery, although definitive proof in man is lacking. This review focuses on new nasal delivery technologies designed to overcome inherent anatomical and physiological challenges and facilitate more efficient and targeted drug delivery for CNS disorders.

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Section: Spay Pumps Drops and Syringes With Tubesmentioning

confidence: 99%

The Nasal Approach to Delivering Treatment for Brain Diseases: An Anatomic, Physiologic, and Delivery Technology Overview

Djupesland

Messina

Mahmoud

2014

Therapeutic Delivery

238

154

View full text Add to dashboard Cite

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“…Materials penetrating the nasal valve available for deposition in the turbinate region are desirable. Both gamma scintigraphic measurements in human volunteers and nasal airway replicas have been used to study the deposition pattern of nasal delivery (62)(63)(64)(65)(66)(67). These studies identify several key parameters including plume angle, droplet size, plume velocity, and inspiratory flow rate that may influence the deposition pattern of nasal spray devices.…”

Section: Nasal Spraymentioning

confidence: 99%

Mechanisms of Pharmaceutical Aerosol Deposition in the Respiratory Tract

Cheng

2014

AAPS PharmSciTech

167

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Abstract. Aerosol delivery is noninvasive and is effective in much lower doses than required for oral administration. Currently, there are several types of therapeutic aerosol delivery systems, including the pressurized metered-dose inhaler, the dry powder inhaler, the medical nebulizer, the solution mist inhaler, and the nasal sprays. Both oral and nasal inhalation routes are used for the delivery of therapeutic aerosols. Following inhalation therapy, only a fraction of the dose reaches the expected target area. Knowledge of the amount of drug actually deposited is essential in designing the delivery system or devices to optimize the delivery efficiency to the targeted region of the respiratory tract. Aerosol deposition mechanisms in the human respiratory tract have been well studied. Prediction of pharmaceutical aerosol deposition using established lung deposition models has limited success primarily because they underestimated oropharyngeal deposition. Recent studies of oropharyngeal deposition of several drug delivery systems identify other factors associated with the delivery system that dominates the transport and deposition of the oropharyngeal region. Computational fluid dynamic simulation of the aerosol transport and deposition in the respiratory tract has provided important insight into these processes. Investigation of nasal spray deposition mechanisms is also discussed.

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“…Scintigraphic techniques have been used to assess nasal deposition and clearance of radiolabeled liquid or powder formulations delivered with a variety of devices. (8)(9)(10)(11)(12) However, these techniques were relatively crude and did not allow for reliable absolute or relative quantification of deposition in well-defined nasal regions. An improved system for regional quantification of deposition and clearance was introduced some years ago, (3) and recently this method was further improved by applying magnetic resonance images (MRI) overlay and by correcting for attenuation of photons as they travel through tissues of different thicknesses and densities from the radioactive source in the nose to the gamma camera.…”

Section: Introductionmentioning

confidence: 99%

Nasal Deposition and Clearance in Man: Comparison of a Bidirectional Powder Device and a Traditional Liquid Spray Pump

Djupesland

Skretting

2012

Journal of Aerosol Medicine and Pulmonary Drug Delivery

135

144

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Gamma scintigraphy for testing bioequivalence: A case study on two cromolyn sodium nasal spray preparations

Cited by 25 publications

References 28 publications

The Nasal Approach to Delivering Treatment for Brain Diseases: An Anatomic, Physiologic, and Delivery Technology Overview

The Nasal Approach to Delivering Treatment for Brain Diseases: An Anatomic, Physiologic, and Delivery Technology Overview

Mechanisms of Pharmaceutical Aerosol Deposition in the Respiratory Tract

Nasal Deposition and Clearance in Man: Comparison of a Bidirectional Powder Device and a Traditional Liquid Spray Pump

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