To ensure efficacy and safety of a drug product, the active compound and its degraded product(s) must be quantified to determine the expiry period of the formulation. Due to the multiplicity of protein degradation pathways, no single test method can be guaranteed to be stability indicating. Only the continued information from various methods can lead to the assurance that the physicochemical integrity and biological activities of a protein are retained throughout manufacturing and shelf life.
- Thermal denaturation (heat as well as cold)
- pH denaturation
- Salt denaturation
- Pressure and shear denaturation
- Surface denaturation and
- Freeze drying denaturation
In addition to monitoring the integrity of the protein primary structure, protein conformation stability at secondary, tertiary and quarternary levels must also be verified to assure maintaining biological function.
Internationally, biotechnology products are regulated under the statutory authority of four federal agencies: the Food and Drug Administration, The Environmental Protection Agency, the Occupational Safety and Health Administration and the United Nations department of Agriculture.
Unlike conventional drugs, peptides and protein drugs have primary, secondary and tertiary structures, all of which must be taken into account in order to gain complete control of the identity, strength, quality and potency of the material. As a result of this, establishing specific standards for the identity, strength, quality, potency and stability of peptide and protein drugs is a complex procedure; the use of the recombinant DNA (rDNA) techniques or hybridoma manufacturing process to produce peptides and proteins introduces additional complexities.
Mucosal adhesive dosage forms are now at the starting line. The advantages are tremendous, which make further study in this field extremely important. The formulation of these drug delivery systems depends on the development of suitable polymers bearing excellent mucoadhesive properties, characteristics, size and molecular weight of peptides, their stability individually and in presence of mucoadhesive polymers and the overall biocompatibility of the dosage form. Obviously as the pharmaceutical industry moves into the area of peptide-based therapies, there will be greater stimulus for development of mucosal and like novel technologies of drug delivery.
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