Biomaterials and Bionanotechnology

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• Publisher: Academic Press
• Year: 2019
• Print ISBN: 9780128144275
• eBook ISBN: 9780128144282
• Topic: Medicine
• Subtopic: Pharmaceutical, Biotechnology & Healthcare Industry

Biomaterials and Bionanotechnology examines the current state of the field within pharmaceutical sciences and concisely explains the history of biomaterials including key developments. Written by experts in the field, this volume within the Advances in Pharmaceutical Product Development and Research series deepens understanding of biomaterials and bionanotechnology within drug discovery and drug development. Each chapter delves into a particular aspect of this fast-moving field to cover the fundamental principles, advanced methodologies and technologies employed by pharmaceutical scientists, researchers and pharmaceutical industries to transform a drug candidate or new chemical entity into a final administrable dosage form, with particular focus on biomaterials and bionanomaterials. This book provides a comprehensive examination suitable for researchers working in the pharmaceutical, cosmetics, biotechnology, food and related industries as well as advanced students in these fields. - Examines the most recent developments in biomaterials and nanomaterials for pharmaceutical sciences - Covers important topics, such as the fundamentals of polymers science, transportation and bio interaction of properties in nanomaterials across biological systems, and nanotechnology in tissue engineering as they pertain specifically to pharmaceutical sciences - Contains extensive references for further discovery on the role of biomaterials and nanomaterials in the drug discovery process

Chapter 1

Design of Materials and Product Specifications

Divya Pandit¹, Pran Kishore Deb² and Renu Chadha¹, ¹University Institute of Pharmaceutical Sciences (UIPS), Panjab University, Chandigarh, India, ²Faculty of Pharmacy, Philadelphia University, Amman, Jordan

Abstract

A pharmaceutical industry is governed by specific regulatory bodies where the quality of any pharmaceutical product is given prime importance. Drug development process requires thorough planning to avoid failure to meet quality allied goals. Improper process designing leads to the quality deficit product, resulting in massive loss of company’s share in the market. Therefore, various guidelines have been implemented relevant to the design and development of the high-quality pharmaceutical product. Designing of specification in various aspects of drug development is considered as one of the most crucial steps for maintaining quality standard. In the present chapter, the basic objectives of designing the specification of drug substance and drug product have been explained while highlighting its importance and scope. Detail account of the guidelines has also been mentioned for better understanding to contextualize the chapter.

Keywords

Drug design; specifications; guideline; drug substances; drug product; drug quality

Outline

• 1.1 Introduction 2
• 1.2 Objectives and Scope of Design of Materials and Product Specifications 2
• 1.3 Pharmaceutical Product Specification 3
  • 1.3.1 Concepts and the Need 3
  • 1.3.2 The Rationale for Designing Specifications 3
  • 1.3.3 Associated Terminologies 4
  • 1.3.4 Types of Specifications 4
• 1.4 Designing of Specification 5
  • 1.4.1 Guidelines for Designing Specification for Drug Substance/Drug Product 5
  • 1.4.2 Guidelines for Designing Specification for Packaging Material 10
• 1.5 Handling of Out-of-Specification 11
  • 1.5.1 Phase I Investigation 12
  • 1.5.2 Phase II Investigation 12
• 1.6 Finished Pharmaceutical Product 12
  • 1.6.1 Regulatory Requirements 12
  • 1.6.2 Schematic Plan for Verification of Specification 14
  • 1.6.3 Labeling 14
  • 1.6.4 Shelf-Life and Storage 14
• 1.7 Importance of Specification on Pharmaceutical Quality System 15
• 1.8 Conclusion 15
• Acknowledgment 16
• Abbreviations 16
• References 16
• Further reading 17

1.1 Introduction

It is the prerequisite responsibility of pharmaceutical companies to ensure that patients receive effective medicines of good quality. Manufacturers require assistance in the form of a comprehensive quality system model for implementation to meet their intended purpose and protect public health. This led to the establishment of various guidelines with a mandate to develop, establish and promote standards for the delivery of health care with respect to pharmaceuticals. However, these guidelines are a minimum requirement that is periodically reviewed and revised with the inception of new technological developments.

One of the control strategies for confirming the quality of the pharmaceutical product is to design raw material and finished product specification. During the International Conference of Drug Regulatory Authorities, officials from the United States, European Union (EU), and Japan felt a need to harmonize the requirements of pharmaceutical products, which led to the establishment of International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceuticals for Human Use (ICH), with observers from WHO, Canada, and EFTA (Handoo et al., 2012). According to ICHQ6 (Quality guideline of International Conference on Harmonization of technical requirements for registration of pharmaceuticals for human use), specifications are the critical quality standard of tests in the form of numerical value or range to which a drug substance or drug product should conform (ICH, Q6A, 1999).

1.2 Objectives and Scope of Design of Materials and Product Specifications

A drug substance or its product needs to comply with the pharmacopoeial monograph. In case the monograph is not available then it should comply with the specifications mentioned in the NDA (new drug application). Regulatory authorities of some important pharmaceutical markets like the United States, EU, and Japan took an initiative to harmonize NDAs in the form of ICH guidelines to decrease the differences in technical requirements of various regulatory agencies for drug development. The ICH provided a platform for harmonization through feedback from both industry and regulatory representatives. ICHQ6A is one of the key ICH guidelines that is concerned with the specifications of new drug substances and drug products, while ICHQ6B deals with specification designing for biologicals (ICHQ6, 1999). The Food and Drug Administration (FDA) published a guidance pertaining to it with an objective to establish a single set of global specifications for new drug substances and their products (FDA, US, 2000).

The main objective of ICHQ6 is to identify the critical quality attributes that impact safety and efficacy of the drug substance or drug product and provide the reference to analytical procedures for their testing with acceptance criteria while maintaining the adequate accuracy and precision. Besides this, quality by design (QbD) approaches and clinical experience are the tools that are employed in establishing the specifications and nowadays this data is solicited by regulatory agencies like FDA. All the manufacturers need to propose and justify their acceptance criteria to regulatory authorities in the form of specifications for approval. This led to the thorough characterization of raw materials and final products by the manufacturers to ensure that they don’t put the patient at risk due to inadequate safety, quality, or efficacy of the pharmaceutical product. Hence, designing of specification became an indispensable step in pharmaceutical product development.

1.3 Pharmaceutical Product Specification

1.3.1 Concepts and the Need

The specification is a quality standard that determines the most appropriate means for reaching the stated objective of the manufacturer. Specifications cover general quality characteristics of the pharmaceuticals particularly related to pharmacotechnical aspects. Monographs or general chapters in pharmacopeia provide approved specifications. Some relevant information is also obtained by technical guidelines. For example, besides the ICHQ6 guideline, Q1, Q3, Q4, Q8, Q9, Q10 on stabilities, impurities, pharmacopeia, pharmaceutical development, quality risk management, and pharmaceutical quality system, respectively, are helpful in identifying the critical quality attributes and quantitative development of the acceptance criteria. An appropriate specification for each aspect of quality studied during the phase of development and during the validation of the manufacturing process should be determined as the applicant has to furnish appropriate analytical validation data in the marketing authorization application (MAA). The width of the upper and lower specification limits affect the shelf-life of the product. The tighter the specification limits, the higher are the chances of batch rejection, whereas the broader the specifications, the higher the incidences of acceptance of poor quality of the pharmaceutical product (Riley et al., 2013).

The regulatory authorities recognize that only a limited amount of data may be available at the time of filing. Therefore, the revised acceptance criteria can be proposed later when adequate data is available. Hence, the industry has an opportunity to loosen or tighten their specification based on the data with justification for each procedure and related acceptance criterion (FDA, US, 2000). The quality of drug substances and drug products is judged by the specifications applied to them throughout development, therefore, designing of specifications need to be done cautiously with appropriate justification.

1.3.2 The Rationale for Designing Specifications

Specifications are one of the essential...

Table of contents

• Cover image
• Title page
• Table of Contents
• Copyright
• Dedication
• List of Contributors
• About the Editor
• Chapter 1. Design of Materials and Product Specifications
• Chapter 2. Engineered Mesenchymal Stem Cells as Nanocarriers for Cancer Therapy and Diagnosis
• Chapter 3. Guiding Factors and Surface Modification Strategies for Biomaterials in Pharmaceutical Product Development
• Chapter 4. Biomaterials for Sustained and Controlled Delivery of Small Drug Molecules
• Chapter 5. Biotechnology-Based Pharmaceutical Products
• Chapter 6. Approaches to the Development of Implantable Therapeutic Systems
• Chapter 7. Nanotechnology in Tissue Engineering
• Chapter 8. Novel Therapeutic Approaches for the Treatment of Leishmaniasis
• Chapter 9. Up-to-Date Implications of Nanomaterials in Dental Science
• Chapter 10. Current Research Perspectives of Orthopedic Implant Materials
• Chapter 11. Biomaterials and Nanoparticles for Hyperthermia Therapy
• Chapter 12. Hyaluronic Acid as an Emerging Technology Platform for Silencing RNA Delivery
• Chapter 13. Thiolated-Chitosan: A Novel Mucoadhesive Polymer for Better-Targeted Drug Delivery
• Chapter 14. Recent Advances and Challenges in Microneedle-Mediated Transdermal Protein and Peptide Drug Delivery
• Chapter 15. Synthesis, Characterization, and Applications of Metal Nanoparticles
• Chapter 16. Functionalized Carbon Nanotubes for Protein, Peptide, and Gene Delivery
• Chapter 17. Surface Modifications of Biomaterials and Their Implication on Biocompatibility
• Index