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New 2016/17 Advanced, rewritten edition promoting current state-of-Art requirements.

Promotes the development and sharing of practical drug development knowledge and Aero technology by agency and industry experts alike.

The world's most definitive & authoritative current generic drug development series available anywhere.

 

LOCUM INT. PRESS
Vol, Edition # and Pub. Year.

H/B Vol (9A / Ed 16 - 2016
H/B Vol (9A / Ed 17 - 2017
H/B Vol (9A / Ed 18 - 2018
H/B Vol (9A / Ed 19 - 2019
H/B Vol (9A / Ed 20 - 2020
H/B Vol (9A / Ed 21 - 2021
H/B Vol (9A / Ed 22 - 2022
H/B Vol (9A / Ed 23 - 2023
H/B Vol (9A / Ed 24 - 2024

New Edition Annually

Locum Publishers Clients
(Handbooks and Journals)

This extraordinary publication is a 'must have' reference for every developer, researcher and manufacturer in the Inhalation technology field - IAGIM DRUG RESEARCH INSTITUTE.

SPECIAL NOTE
Launch Date for New Redesigned advanced Issue:
Ed. 9A Available Sept/October 2016.

Handbook Generic Development Inhalation Aerosols - MDI & DPI
A Two Part Development To Final Production Handbook

Locum International Press.

Volume 9A - (Complete Handbook in Two Parts)
of the International 24 Volume Drug Development Series


This highly advanced drug development Handbook of Pharmaceutical Generic Development covers the key essential aspects of the development, formulation, scale-up, validation and pivotal and commercial validated manufacture of Pharmaceutical MD and DP Aerosol Inhalers including, spacers and nebulizers. R&D associates are guided through every specification and test requirement from small scale to large batch manufacture with automatic leaker testing on-line equipment.
Pressurized Metered Dose Inhalers (pMDI) are widely used for the treatment of asthma and COPD1. All aspects of the design are tailored to enable efficient and consistent dose delivery to the patient. The design hardware include a canister (Al) of specific size volume to contain sufficient formulation (dissolved or suspended (~1%)) for the required number of doses, via a metering valve capable of delivering a consistent amount of formulated active ingredient and essential excipients with each delivered, counted4 dose through an actuator mouthpiece (shaped and designed) that atomizes the formulation and acts as a conduit mouthpiece delivering the precise dose to the patients' mid and/or deep lung, minimizing active deposition in the mouth and throat. Spacers may be used with the pMDI

Detailed analysis of all marketed Aerosol formulations from early product development to critical material specifications of the container, valve, actuator, closure specifications, formulation excipients (propellants, solvents, co-solvents2, Lipids, surfactants (oleic acid, miglyol 840, tweens), pH, in-situ reactions) and critical active material ingredient preparation in terms of PS and crystal morphology. Latest advances in plume geometry and particle size3 (APSD) analysis and distribution specifications, Aerodynamic Particle Size Distribution (ASPD), and (MMAD) Micronized Drug Mass Medium Aerodynamic Diameters and testing are fully constructed and explained in clear detail. The disposition location in the lung is used as a measure of efficacy of the inhaler. Use of Spacers with pMDI's - different types/sizes

This Handbook promotes the development and sharing of practical drug developmental knowledge and pressurized Aerosol Metered Dose (liquids or suspensions) as well and dry powder inhalation technology from government agency and industry experts alike.

Authors integrated carefully and specifically the FDA review chemist's in-house working documentation to integrate the applicant product development and simultaneous FDA review chemists specific tabulated expectations and box checked requirements. This ground breaking approach and unique writing style in development and research is a first worldwide in advanced technical handbook developmental literature. [Authors overall objective - product must pass review.
]

Each and every DPI applicator is listed, tabulated and dissected.
The handbook functions as both a working manual and Authoritative Reference Works with example template, protocols and finely-tuned formulation guides with detailed descriptions of all key and critical matters pertaining to pharmaceutical aerosol development that range through pivotal, clinical and stability batches all the way to validated commercial production.

Covering pharmaceutical drug development by providing hands-on easy-to-understand current know-how for the inhalation product development team, re: formulation, container-closure-valve-actuator, scale-up, process optimization and qualification, GMP, aseptic procedures, stability, pivotal and commercial validation procedures of production batch lots (Aqueous and lyophilized) with supporting SOPs, protocols and checklists at every development and processing stage.

SEAMLESS INTEGRATION
An Essential Reference for Development Pharmacists, R&D Chemists, QA/QC and Regulatory personnel. Each and every document, protocol and procedure in Part I + II is expertly referenced to the appropriate module number in the CTD / e-CTD system thus providing a fully seamless and effortless integration into either US, EU and Asian application files and dossier. All IAGIM technology is purposely and uniquely dovetailed in regulatory drug product applications - worldwide applications made simple and precise. Labeling and clear instructional patient use and routine daily use practice is of critical concern in obtaining the proper and effective benefits from this challenging dosage route

Includes IQ, OQ, PQ and equipment validation and comprehensive validation checklists up to end-process validation, analytical, cleaning and process validation, critical and essential documentation peppered with extensive legal and regulatory know-how that is essential for a first time successful review for a FDA approval, saving queue-time and lost market sales.
1- Chronic Obstructive Pulmonary Disease
2- Ethyl Alcohol : HFA 134a (8.5 : 91.5w/w) HFA is 1,1,1,2-Tetrafloroethane a Non-CFC (phased out)
3-1.1 -2.5 microns of [drug] < 1%
Particle deposition bypassing the oropharyngeal region to the desired Bronchial (mid-lung) or deep lung region.
4
- Inhalers with dose counters (critical in patient use and compliant studies/publications)
Complete Volume in Two Parts 1990-2000 pp. Part 1 and 2 fully illustrated and annotated with diagrams, flow charts, formula, graphs, spectra, side-by-side comparisons, tables in b/w & color. Available in print (spiral soft cover opens flat for R&D environment)

ISSN 0793-8754 / 0793-8844


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