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Sodium Cromolyn 4% nasal drops is a bronchial anti-inflammatory and mast cell inhibitor in the treatment of allergic rhinitis. In the present study, a high-performance liquid chromatography method was validated to evaluate the analytical behavior and stability of Cromolyn Sodium 4% nasal drops. The method was based on the separation of the active principle through an Apollo-C8 chromatographic column; 5µm; 150mm x 4.6mm; with ultraviolet detection at 326 nm, for which mobile phase A and B were prepared; consisting of mobile phase A: Tetrabutylammonium hydrogen sulfate solution (10 g/L), acetonitrile (95:5) and mobile phase B: Tetrabutylammonium hydrogen sulfate solution (10 g/L), acetonitrile, methanol (50:25 :25); with a flow rate of 1.5 mL/min. The calibration curve was carried out in the concentration range of 1.25 to 1.87 10-4 mol/L, (from 80% to 120%) of the pharmaceutically active ingredient in the finished product. The method was sufficiently linear, precise and accurate in the range of concentrations studied. In addition, it was specific against the remaining components of the matrix and the possible degradation products obtained under stress conditions. [ABSTRACT FROM AUTHOR]

Because the nasal mucous is one of the most permeable areas, the intranasal delivery route is the most promising for proteins and peptides to reach the central nervous system (CNS). Nevertheless certain aspects of these macromolecules limit their bioavailability, such as molecular weight, the rapid mucociliary clearance mechanism and enzymatic degradation. This paper critically summarizes the factors participating in the design of systems for the nasal delivery of peptides and proteins. The physicochemical properties of the biomolecules and features of the formulation design that directly influence their bioavailablity and stability are presented. Pharmaceutical aspects include an analysis of the influence of excipients that act as stabilizers, antimicrobial preservatives, absorption enhancers, and bioadhesive polymers as well as the administration device. The use of molecules involved in endogenous neuroprotection administered intranasally is a recent proposal in the development of new drugs. Neurotrophic factors, interferon beta-1b, erythropietin (i.e.: rH-EPO, Neuro-EPO) and insulin, are among the biotechnology products administered intranasally. These new products show greater therapeutic potential as putative neuroprotectors in neurological diseases, both for treatment during the acute phase, and for the chronic stage. [ABSTRACT FROM AUTHOR]

Because the nasal mucous is one of the most permeable areas, the intranasal delivery route is the most promising for proteins and peptides to reach the central nervous system (CNS). Nevertheless certain aspects of these macromolecules limit their bioavailability, such as molecular weight, the rapid mucociliary clearance mechanism and enzymatic degradation. This paper critically summarizes the factors participating in the design of systems for the nasal delivery of peptides and proteins. The physicochemical properties of the biomolecules and features of the formulation design that directly influence their bioavailablity and stability are presented. Pharmaceutical aspects include an analysis of the influence of excipients that act as stabilizers, antimicrobial preservatives, absorption enhancers, and bioadhesive polymers as well as the administration device. The use of molecules involved in endogenous neuroprotection administered intranasally is a recent proposal in the development of new drugs. Neurotrophic factors, interferon beta-1b, erythropietin (i.e.: rHEPO, Neuro-EPO) and insulin, are among the biotechnology products administered intranasally. These new products show greater therapeutic potential as putative neuroprotectors in neurological diseases, both for treatment during the acute phase, and for the chronic stage. [ABSTRACT FROM AUTHOR]