New 2016/17 Advanced, rewritten edition promoting current state-of-Art
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 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 Updated 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.
Launch Date for New Redesigned advanced Issue:
Ed. 9A Available Sept/October 2016.
- MDI & DPI
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
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.
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)
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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