Image > Creating Tomorrow’s Packaging Today:
Technology and Collaboration-Based Approaches to Optimize Pharmaceutical Package Design

Creating Tomorrow’s Packaging Today: Technology and Collaboration-Based Approaches to Optimize Pharmaceutical Package Design

SOS-2015
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Session Description: This session will examine existing and emerging challenges in pharmaceutical package design including product stability, branding, cost, regulatory and patient compliance. Examples of new approaches backed by science-based predictive technologies to overcome these challenges much more rapidly and inexpensively than traditional trial and error will be presented.

Session Abstract: Bringing a new pharmaceutical product to market involves answering many questions about packaging, including branding, design, cost, regulatory concerns and patient compliance. Equally important is ensuring packaging materials, design and production are optimized for the particular needs of the product, including the equipment, transportation, climate and patients with which it will interact. Product stability and integrity must be preserved – and packaging is its first and last line of defense. Traditional methods of determining package suitability often involve costly trial and error and lengthy stability tests. New advances in materials sciences and predictive modeling are causing a paradigm shift in how packaging is designed and used by manufacturers and consumers. Examples demonstrate how technology, suppliers, pharma companies and end users all contribute to a collaborative process that can quickly generate innovative and optimized package designs that better address operational and patient needs.

Image ASAP Fundamentals – Garry Scrivens

ASAP Fundamentals – Garry Scrivens

SOS-2015
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Accelerated Stability Assessment Protocols (ASAPs) are gaining increasing acceptance across the pharmaceutical industry as a means of predicting shelf life and understanding the effects of temperature and humidity on pharmaceutical stability.

In this presentation the theory and fundamentals of ASAPs are reviewed and discussed, covering topics such as the shapes of degradation profiles and reviewing the theoretical basis and experimental evidence for various ASAP models.  Some recent attempts to understand the effects of temperature and humidity on solid-state chemical degradation at a molecular level are also described.

Image Application of ASAP in early API and formulation development

Application of ASAP in early API and formulation development

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This presentation discusses the scientific and risk basis of using alternative stability assessment approaches in early API and formulation development.

During early clinical development, turnaround time is crucial to support a fast paced project timeline. Alternative approaches such as ASAP fits into the early development environment nicely for providing fit-for-purpose stability assessment of drug candidates and formulations prototypes. Example areas of application include but not limited to the following:

  • General stability screening of drug candidates
  • Establishing initial retest period for drug substances
  • Evaluate drug substances lot to lot stability variations
  • Evaluate stability of prototype formulations
  • Support process/formulation optimization
  • Support shelf life of clinical supplies

Abstract: ASAP Assumptions and the Impact on Predictions:
Case Study on controlling Mutagenic Degradation

ASAP Assumptions and the Impact on Predictions: Case Study on controlling Mutagenic Degradation Accelerated stability programs have become an integral part of pharmaceutical development. An understanding of the assumptions that go into those projections are critical to the accuracy.  For example, the activation energy, humidity correction, the time of...

Image Abstract: Predicting the Degradation Rate as a Function of Drug Load in Solid-State Drug Products

Predicting the Degradation Rate as a Function of Drug Load in Solid-State Drug Products

A model for predicting the rate of degradation as a function of drug load was recently developed (J. Pharm. Sci., 101(11), 2012, 4170-4177). In this case study, we explore both the mathematical model as well as the conceptual construct from which the model was developed.  We applied the model to a pediatric formulation of prasugrel hydrochloride of varying drug loads.  Our results confirm the validity of the mathematical model, but call into question the proposed conceptual construct.  We will discuss the generality of the model and how the use of this model can speed development of lower dose drug formulations typically found in pediatric dosing regimens.

Allison Dill – Lilly Pharmaceuticals

Image Full System Moisture Management for Drug Preservation

Full System Moisture Management for Drug Preservation

SOS-2015
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Moisture is a primary factor that can affect the stability of pharmaceuticals.  Exposed to excessive humidity, capsules can swell and aggregate, powdered ingredients can clump and moisture might directly affect the chemical stability of the drugs. All of these changes of physical or chemical properties can cause a drug to lose its efficacy before the end of its shelf life.

 The role of desiccants is to preserve drug products by addressing the moisture that can enter the microenvironment of the package from various sources including: moisture trapped in the headspace during packaging or released from the drug product itself; moisture vapor transmission through pharmaceutical bottle walls throughout shelf life; and ingress during open-close cycles by the patient.

 Addressing the question of drug preservation requires us to think of the packaging as a full system, combining the performance of the passive barrier with active management of the atmosphere within packaging’s headspace.

 The discussion will explore :

  • The parameters influencing the barrier properties of the container
  • The selection of the appropriate active material and amount of desiccant
  • The available options for integrating moisture management into the latest delivery systems
  • The latest developments in desiccant technologies to maintain an accurate humidity window where excessive moisture or excessive dryness are both a challenge

Image Abstract: Applications of Accelerated Stability Assessment Program (ASAP) in Pharmaceutical Development

Applications of Accelerated Stability Assessment Program (ASAP) in Pharmaceutical Development

SOS-2015
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The presentation describes examples in utilizing the Accelerated Stability Assessment Program (ASAP) to support various areas of application within a commercial space. Using the Arrhenius principle in combination with moisture transfer modeling and statistical data analysis, the program has provided support for formulation screening to achieve the ranking order required to deliver rapid decision pertaining to the optimal formulation.

ASAP modeling has also served as a risk assessment tool during the evaluation of packaging configurations for moisture protection of drug products and API/excipient qualification as means of minimizing cycle time of traditional screening processes. The presentation will focus extensively on the role ASAP plays in supporting a root cause investigative study into the stability issues associated with a given drug product. The presentation will also discuss the application of predictive models as an accelerated means of ascertaining the impact that various exposure levels will have on the long term stability behavior of the product degradation over its shelf life.

Applications of Accelerated Stability Assessment Program (ASAP) in Pharmaceutical Development
Llurellyn Malcolm,
Pfizer, Pearl River, New York, USA

 

Image Abstract: Film Coating for Protection during In-Use Applications

Film Coating for Protection during In-Use Applications

Film coating provides a number of advantages from product protection and packaging efficiencies, through improved swallowability, better differentiation and patient compliance.  Barrier coatings provide the final layer of moisture protection after the product is removed from the primary packaging.  Recent advances in moisture barrier coating systems are presented.

Recent Advances in Functional Coatings for Immediate Release Dosage Forms
Jason Teckoe,
Colorcon, Harleysville, PA, USA

Image SOS-2015 Case Studies: Stress Testing Revealing Degradation Pathways:

Stress Testing Revealing Degradation Pathways:

SOS-2015
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Despite a thorough stability assessment, unexpected degradation processes can occur throughout every phase of drug development or even after market launch.

Since drug decomposition may have a myriad of manifold root causes, a well designed forced degradation strategy can help to reveal potential stability issues long before requiring exceptional financial and personnel expenditures to be resolved.

The presented case studies illustrate how forced degradation and subsequent investigations helped to identify, understand, and tackle degradation issues in a systematic way.

Image Abstract: Modeling of Degradation Chemistry at AstraZeneca

Modeling of Degradation Chemistry at AstraZeneca

SOS-2015 Astra Zeneca
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One key step in the drug product development process is to select which aggregation state the active pharmaceutical ingredient (API) should have to obtain optimal product and process performance. The objective at the form selection step is to choose the preferred aggregation state of the API with respect to a large number of requirements on the material. Requirements can be expressed in terms of high level materials performance characteristics.

  • Consistent and predicable bioavailability
  • Robust and scalable manufacturing process
  • Predicable chemical and physical stability

In this talk the emphasis is on how computational methods could be used to understand the risk associated to chemical degradation of the API. Autoxidation and oxidation of hetro atoms will be discussed.

Image Abstract: Excipient Compatibility as Predicted by ASAP: A Case Study

Excipient Compatibility as Predicted by ASAP: A Case Study

SOS-2015
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With the advent of the Accelerated Stability Assessment Program (ASAP), a novel approach to excipient compatibility testing is now possible. Formulation development begins with the process of selecting excipients that do not adversely affect the chemical stability of the drug substance. Traditionally, excipient compatibility studies have been a time consuming process as each potential excipient was evaluated by preparing an API-excipient binary mixture at 1:1 ratios and stored at accelerated conditions. The blends were then tested over multiple weeks and often generating results that require investigation thus further prolonging entry into formulation development.

Alternatively, testing multiple prototype formulations within the ASAP platform can be accomplished in a matter of weeks with greater understanding of critical excipient compatibilities, final product storage conditions, and degradation formation. Following rapid ASAP excipient compatibility studies CMC scientists are more informed and prepared to quickly enter into full formulation development. Chromatographic analytical methods can be a rate limiting step in the application of ASAP to early excipient capability studies.

An alternative approach to sample analysis paired with ASAP should be investigated further decreasing cost and product timelines.   This presentation will discuss a case study investigating three prototype formulations each containing unique fillers with the potential for incompatibilities.   The prototype samples were additionally analyzed by an alternate analytical technique and results inputted into ASAP to determine when compared to a traditional chromatographic method would the same incompatibilities be predicted.

Excipient Compatibility as Predicted by ASAP: A Case Study
Jerusha Thompson,
Upsher-Smith, Maple Grove, Minnesota