Effects of formulation variables on nasal epithelial cell integrity: Biochemical evaluations

Pujara, Chetan P.; Shao, Zezhi; Duncan, Michelle R.; Mitra, Ashim K.

doi:10.1016/0378-5173(94)00238-z

Cited by 52 publications

(28 citation statements)

References 11 publications

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“…A pH range between 3 and 10 can be tolerated, even though subjective discomfort may occur at the extremes of this range. However, studies on animal models demonstrated no occurrence of mucosal damage with solutions between pH 3 and 10 [27]. …”

Section: Discussionmentioning

confidence: 99%

Efficacy of Buffered Hypertonic Saline Nasal Irrigation for Nasal Symptoms in Children with Seasonal Allergic Rhinitis: A Randomized Controlled Trial

Malizia¹,

Fasola²,

Ferrante³

et al. 2017

Int Arch Allergy Immunol

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Background: Saline nasal irrigation is labelled as an add-on treatment in patients with allergic rhinitis (AR). The primary aim of this study was to compare the efficacy of 21-day use of buffered hypertonic saline (BHS) versus normal saline solution (NSS) on reducing nasal symptoms in children with seasonal AR (SAR). Comparing their efficacy on nasal cytology counts (NCC), quality of life, and sleep quality was the secondary aim. Methods: In this 21-day,open-label, randomized controlled study, 36 SAR children (aged 6-13 years) with a Total 5 Symptom Score (T5SS) ≥5 received twice-daily BHS or NSS delivered through a nasal douche. Efficacy measures were least square mean changes (LSmc) in T5SS, NCC, Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ), and Pittsburgh Sleep Quality Index (PSQI) scores. Results: BHS improved the T5SS total score to a greater extent than NSS (LSmc -6.45 vs. -5.45, p < 0.001). Concerning NCC, BHS significantly reduced the scores of neutrophils (LSmc -0.76, p = 0.004) and eosinophils (LSmc -0.46, p = 0.018), while NSS did not. Similarly, only BHS yielded a significant improvement in the PRQLQ score (LSmc -0.57, p = 0.009), whereas the improvement in PSQI score was comparable between the BHS (LSmc -0.77, p = 0.025) and NSS (LSmc -1.39, p < 0.001) groups. Overall, BHS was well tolerated. Conclusions: In children with SAR, BHS is effective in improving nasal symptoms and NCC, with an associated beneficial effect on quality of life.

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Section: Discussionmentioning

confidence: 99%

Efficacy of Buffered Hypertonic Saline Nasal Irrigation for Nasal Symptoms in Children with Seasonal Allergic Rhinitis: A Randomized Controlled Trial

Malizia¹,

Fasola²,

Ferrante³

et al. 2017

Int Arch Allergy Immunol

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“…Moreover, it interacts strongly with nasal mucus layer enhancing the contact time for the transport of the drug across the membrane (4, [143][144][145]. Finally, chitosan also enhances the dissolution rate of low water soluble drugs (120,128). Consequently, chitosan is used in several intranasal pharmaceutical forms, including powders, liquids, gels, microparticles and microspheres.…”

Section: Chitosanmentioning

confidence: 99%

“…Besides, the pH often prevents the bacteria growth (11). In order to evaluate the effect of pH solution on the integrity of nasal mucosa, Pujara et al (128) dissolved drugs in phosphate buffer at different pH values in the range of 2-12. The study was performed in rats whose nasal pH is 7.39 (121) and the results demonstrated that when pH ranged from 3-10 minimal quantities of proteins and enzymes were released from cells, demonstrating no cellular damages.…”

Section: Phmentioning

confidence: 99%

Intranasal Drug Delivery: How, Why and What for?

2009

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Over the recent decades the interest in intranasal delivery as a non-invasive route for drugs is increased. Since the nasal mucosa offers numerous benefits as a target tissue for drug delivery, a wide variety of therapeutic compounds may be administered intranasally for topic, systemic and central nervous system action. We have, herein, outlined the relevant aspects of nasal anatomy, physiology and histology, and the biological, physicochemical and pharmaceutical factors that must be considered during the process of discovery and development of nasal drugs as well as in their incorporation into appropriate nasal pharmaceutical formulations. _______________________________________________________________________________________

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“…The olfactory region is covered with a mucus layer (∼5 μm thick), which consists of a lower solution layer and an upper gel layer. The normal pH range of nasal mucus is approximately 5.5-6.5; however, the nasal mucosa tolerates solutions having a pH range of 3-10 [26].…”

Section: Nasal Anatomy and Physiologymentioning

confidence: 99%

Influence of Dosage Form, Formulation, and Delivery Device on Olfactory Deposition and Clearance: Enhancement of Nose-to-CNS Uptake

2015

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Nose-to-central nervous system (CNS) drug delivery has shown promising results in preclinical efficacy models and exploratory human clinical trials. There are two primary limitations to direct CNS uptake of drugs following intranasal administration. Firstly, non-specific deposition in the nasal cavity leads to systemic absorption instead of CNS absorption, altering CNS bioavailability. Secondly, mucociliary clearance affects the residence time of the formulation at the site of deposition. In vivo results have demonstrated that therapeutic agents targeted to the olfactory region can translocate directly into the CNS via neuronal uptake. In this review, liquid and solid formulations are investigated for their effect on olfactory deposition and clearance based on their physical properties. The influence of delivery device and mode of administration is also reviewed. Case examples are provided to illustrate the importance of optimal deposition in olfactory region.

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Effects of formulation variables on nasal epithelial cell integrity: Biochemical evaluations

Cited by 52 publications

References 11 publications

Efficacy of Buffered Hypertonic Saline Nasal Irrigation for Nasal Symptoms in Children with Seasonal Allergic Rhinitis: A Randomized Controlled Trial

Efficacy of Buffered Hypertonic Saline Nasal Irrigation for Nasal Symptoms in Children with Seasonal Allergic Rhinitis: A Randomized Controlled Trial

Intranasal Drug Delivery: How, Why and What for?

Influence of Dosage Form, Formulation, and Delivery Device on Olfactory Deposition and Clearance: Enhancement of Nose-to-CNS Uptake

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