Science and Engineering Principles Applied to Pharmaceutical

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					                       2007 Annual Meeting Programming: PT
                             Highlights and Discussions

Science and Engineering Principles Applied to Pharmaceutical Technology for Solid
Formulations (Sunday AM, Short Course)
Bradley Clark and Jian-Xin Li

Pharmaceutical technology is an interdisciplinary branch of engineering. There is a need
for pharmaceutical scientists to proactively engage science and engineering and other
interdisciplinary fields to solve challenging formulation and processing problems for
solid dosage forms.

Advances in Analytical Techniques for Preformulation Support in Pharmaceutical
R&D (Wednesday PM, Symposium)
Eric Munson and Partha Mukherjee

Over the past few years, new analytical technologies have emerged to support
preformulation development in pharmaceutical R&D. These technologies assist in areas
as diverse as preformulation potency and stability assays, chiral purity assays of active
moieties, chiral interconversion possibilities, evaluation of in-situ salt selection of
research compounds, preformulation vehicle selection, and equilibrium and intrinsic
solubility assays of target compounds in intended vehicles. The primary goals of these
analytical technologies are to provide accurate results in a rapid turnaround time for
transfer to the formulator and safety assessment or other relevant drug research areas.
New developments in the area of supercritical fluid chromatography direct assay of
pharmaceutical dosage forms and various hyphenated analytical techniques have been
recently promoted/implemented/evaluated by pharmaceutical companies as highly
efficient routine tools for preformulation assays. In addition, advances in techniques for
characterization of solid dosage forms are leading to prediction of physical and chemical
stability as a function of preparation and processing.

Using PAT Effectively (Wednesday AM, Symposium)
Sharmista Chatterjee

The process analytical technology (PAT) framework encourages implementation of
continuous real-time quality assurance. Process monitoring and control strategies are
intended to monitor the state of the process and actively manipulate it to maintain a
desired state (feed-back or feed-forward control).

Selection of Efficient Cleaning Validation Strategies (Monday AM, Roundtable)
Sharmista Chatterjee

One of the most time-consuming efforts in validation is for cleaning validation. This
effort must consider some or all of the following: very low acceptable change over
residue levels, the number of batches in a campaign, the time for the campaign, the "dirty
hold time," and the "clean hold time." You also have to factor into analysis time for
active pharmaceutical ingredient (API) residue, cleaning agent residue, and microbial
levels after cleaning.

Supply Chain Optimization in the Pharmaceutical Industry—Drivers and
Challenges (Tuesday PM, Symposium)
Vidya Swaminathan

Pharmaceutical companies are faced with pricing pressures, shrinking margins, and
aggressive product development and registration timelines. Manufacturing and
distribution costs are becoming a bigger component of overall costs in large
pharmaceutical manufacturing and contract manufacturing companies. In an effort to
improve their overall efficiency and realize potential savings, these companies are
seeking to optimize their supply chains. Approaches taken to achieve this objective
include consolidation of manufacturing sites and distribution networks and the adoption
of high-throughput manufacturing platforms. Mergers and acquisitions add to the
complexity of integrating the supply chains of the legacy companies. These changes have
an impact on how processes are developed and transferred across sites that can have
different manufacturing equipment and process trains.

Pediatric Drug Development—Identifying the Needs, Meeting the Challenges
(Monday PM , Roundtable)
Lorraine Pena and Joseph Reo

Pediatric labeling for approved drug products has vastly improved over the past 3 years
since the US Food and Drug Administration (FDA) has legislatively been empowered to
take action. The legislation applies to previously approved drug products or newly
approved drug products. The incentive approach is presented in The Best
Pharmaceuticals for Children Act (BPCA) legislation (Public Law 107-109). Under
provisions of the BPCA, a drug firm can obtain up to 6 months of market exclusivity,
provided the drug firm complies with requirements of a written request by the FDA for
conducting clinical studies. The enforcement approach (Pediatric Research Equity Act –
Public Law 108-155) mandates a drug firm to conduct necessary clinical studies to
support pediatric labeling. Although the marketplace has seen significant improvements
in pediatric labeling, of the 114 drug products that have recently added pediatric labeling
(see www.fda.gov/cder/pediatric/labelchange.htm), a pediatric-friendly drug delivery
system does not exist for a majority of them. Perhaps more incentives, engendered from
the FDA or the marketplace, are needed to close the gaps in innovation applied to
formulating products for the pediatric patient population.

Formulation and Stability of Nutraceuticals (Tuesday AM, Roundtable)
Raja Velagapudi

Nutraceuticals are quickly gaining attention due to increasing consumer market share for
wellness products. There has been a heightened focus in the marketing, claims
substantiation, manufacturing, and FDA-based regulations of nutraceuticals. The types of
products that could fall under the nutraceutical umbrella, while loosely defined under
Dietary Supplement Health and Education Act (DSHEA), remain broad. Additionally,
some medical foods are starting to be marketed by prescription typically to get the patient
a reimbursement from insurance companies. The Medical Foods Act, passed by
Congress, requires such foods to be administered under the supervision of a physician.
The manufacturing of such products, however, has been largely unregulated and lacks
desired quality control systems. It can be argued that the European countries have better
regulated such products. The FDA has issued a draft for Current Good Manufacturing
Practices (cGMP) regulations of dietary supplements, which is overdue for finalization.
The potential impact of these pending regulations has already raised concerns within the
manufacturing industry, and the delay in the FDA’s issuance of the final regulations is an
indication of the volume and breadth of the comments received in response to the
proposed regulations.

Functionality Testing of Excipients (Monday AM, Roundtable)
Moji Adeyeye and Richard Moreton

The design of robust formulations requires that we understand the excipients, API and
process, and how they interact. Understanding the properties and limitations of excipients
in pharmaceutical drug product development is as important as the drug characterization
in design and development of the product. This is because excipients, although known as
“inactive ingredients” can interact with active pharmaceutical ingredients in many ways
to affect the in vitro and in vivo performance of the product. Excipient characterization
techniques can range from particle size analysis to spectroscopy, calorimetry, dissolution
analysis, and moisture sorption behavior to in vivo disposition evaluation. Consequences
of a failure to properly understand the raw materials and processes, their variability, and
how they interact can include loss of product (possibly including withdrawal),
unnecessary multiplicity of prototype formulations, changes in physicochemical
properties (stability, solubility, dissolution profile), and inability to obtain successful drug
registration. Excipient functionality testing has been proposed as a means of improving
our understanding of how excipients influence the manufacture and subsequent
performance of drug products.

Evaluation of Pharmaceutical Powder Properties to Ensure Product Quality by
Design (Thursday AM, Symposium)
Jatin Patel and Sailesh Varia

To meet the continued demands of accelerating drug development, there has been a need
to introduce the “commercial” dosage form in clinical studies within 12 to 18 months
after selection of a compound for development. Selection of a suitable formulation and
drug product manufacturing process is required with limited amounts of drug substance
available. To ensure the development of a suitable formulation/manufacturing process,
there has been an increased focus on early characterization of the drug substance and to
determine critical powder properties as it relates to the formulation performance as well
the manufacturing process. Various compaction techniques are currently being used to
guide excipient and/or process choice during the development of a solid dosage form.
New Frontiers in Inhalation (Thursday AM, Symposium)
Julie Suman

The lung has been used as local drug delivery target for many decades. With the approval
of inhaled insulin Exubera, for Type 1 diabetes, opportunities for advanced formulations
and new technologies for pulmonary administration are manifold. There is a need to
highlight novel strategies for advancing inhalation science and bridging among
discovery, preclinical assessment, and excipient selection of novel products.

Introduction into PAT (Tuesday AM, Sunrise Session)
Jukka Rantanen

Getting relevant information from multicomponent systems, such as pharmaceutical unit
operations, is not a straightforward task. Focusing analysis on the end product will not
enable the early detection of problems or further the complex relations between them.
Recently, the FDA introduced a guidance to address this issue. PAT is a system for
developing and implementing new efficient tools for use during pharmaceutical
development, manufacturing, and quality assurance while maintaining or improving the
current level of product quality assurance.