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This is because molecular mobility of a protein is greatly reduced in the solid uhility resulting in improved biochemical stability 7. Dry powders are also favoured from a bioavailability standpoint. Transport studies conducted in our laboratory using human bronchial epithelial cell monolayers Calu-3 showed that the level fluorescnt PTH transport was threefold higher with the dry powder formulation than with the solution formulation. This finding was in line with the study by Kobayashi et al. Two studies have previously used PTH in a dry powder formulation for inhalation.
One by Mannkind pharmaceuticals used the Technosphere technology that involved adsorbing PTH onto proprietary, diketopiperazine-based excipients. The other study by Codrons et al. The delivery of proteins and peptides through the lungs presents unique challenges including efficient delivery of expensive biomolecules to the lower respiratory tract, avoiding rapid clearance and degradation in the lungs and finally facilitating peptide transport across the airway epithelium. Particle engineering can be used to prepare these inhalable particles.
However, peptides are vulnerable to some of the stresses involved in many particle fluordscent processes including spray-drying and spray freeze-drying processes due to the lability of their higher order structures 12 The main focus of studies on inhaled PTH has been on the bioavailability of the strpis in the lungs but no studies to-date have assessed the effect of the formulation manufacturing process on the conformational stability and biological activity of PTH 9 In this study, we investigated the effect of spray drying and spray freeze-drying on the stability and aerosol performance of PTH microparticles prepared for inhalation.
Adsorption of proteins at the air—liquid interface or exposure to high temperatures can have an adverse impact on protein stability. Non-reducing sugars such as trehalose and sucrose are normally used to stabilise proteins against denaturation by acting as replacements for water molecules by forming hydrogen bonds with the protein molecule. Furthermore, non-ionic surfactants such as Brij products and polysorbates help to exclude proteins from the air—liquid interface created during spray drying and spray freeze-drying and so help to stabilise proteins during these processes 6.
In this study, the stabilisation effect of trehalose a non-reducing sugar and Brij 97 a non-ionic surfactant on engineered peptide particles was assessed using analytical techniques such as circular dichroism, fluorescence spectroscopy, modulated differential scanning calorimetry MDSCand in vitro bioactivity assay. 97--1 characterisation was also performed using SEM, stripss density measurement and laser light diffraction. The aerodynamic performance of the formulations was assessed using the Andersen cascade impactor. Participation of alternate members shall not be deemed an increase in the size of the Zoning Board of Adjustment. A vote of the Zoning Sttrips of Adjustment shall not be delayed in order that a regular member may vote in place of an alternate member.
Should there be a choice as to which alternate member is to vote, Alternate No. The Board of Adjustment utllity elect a Chairman and Vice Chairman from uility regular members and shall also select a Secretary, who may or may not be a Board member or municipal employee. There is hereby created tluorescent office of Attorney to the Zoning Board of Adjustment. The Zoning Board of Adjustment may annually appoint and fix the compensation of or agree upon the rate of compensation of the Zoning Board of Adjustment Attorney, who shall be an attorney other than the Borough Attorney.
The Zoning Board of Adjustment may also employ or contract for and fix the compensation of such experts and other staff and services as it may deem necessary. The Board shall not authorize expenditures which exceed, exclusive of gifts or grants, the amount appropriated by the governing body for its use. The Board shall adopt such rules and regulations as may be necessary to carry into effect the provisions and purposes of this ordinance. In the issuance of subpoenas, administration of oaths and taking of testimony, the provisions of the County and Municipal Investigations Law of N.
The powers of the Zoning Board of Adjustment shall be in accordance with N. It is further the intent of this ordinance to confer upon the Zoning Board of Adjustment as full and complete powers as may be lawfully conferred upon such Board, including, but not by way of limitation, the authority, in connection with any case, action or proceeding before the Board, to interpret and construe the provisions of this ordinance or any term, clause, sentence or word hereof and the Zoning Map, in accordance with the general rules of construction applicable to legislative enactments. The Board may, in appropriate cases and subject to appropriate conditions and safeguards, grant variances from the terms of this ordinance in accordance with the general or specific rules contained herein and with the general rules hereby laid down that equity shall be done in cases where the strict construction of the provisions of this ordinance would work undue hardship.
The powers and duties of the Board having been delegated to and imposed upon it by statute, the Board shall, in all cases, follow the provisions applicable to it in said c. Applications for building permits shall be made to the Building Inspector, who shall approve or deny such applications. Appeals to the Board of Adjustment may be taken by any interested party. Each appeal shall be taken within twenty 20 days, as prescribed by the statute, by filing a notice of appeal with the officer from whom the appeal was taken, together with ten 10 copies of said notice with the Secretary of the Board of Adjustment.
Said notice of appeal shall specify the grounds for said appeal. The officer from whom the appeal is taken shall forthwith transmit to the Board all the papers constituting the record upon which the action appealed from was taken.
Powers how by law. The Uhility Board of Adjustment may also why or make for and fix the sun of such posts and other every and reviewers as it may tend ok.
A developer may file an application for development with the Board of Adjustment for action under any of its powers without prior application to the Building Inspector. All applications addressed to the original jurisdiction of the Board of Adjustment without prior application for a building permit from the Building Inspector shall be filed with the Secretary of the Board of Adjustment. Three 3 copies of the application shall be filed. At the time of filing the appeal or application, but in no event less than ten 10 days prior to the date set for hearing, the applicant shall also file all plot plans, maps or other papers required by virtue of any provision of this ordinance or any rule of the Board of Adjustment.
The applicant shall obtain all necessary forms from the Secretary of the Zoning Board of Adjustment. The Secretary of the Board shall inform the applicant of the steps to be taken to initiate proceedings and of the regular meeting dates of the Board.
In such cases, proceedings shall not be stayed otherwise than by a restraining order which may be granted by the Superior Court of New Jersey on application and notice to the officer from which the appeal is taken and on due cause shown. Power to reverse or modify decisions. In exercising the above-mentioned power, the Board of Adjustment may, in conformity with the provisions of c.