Application of freeze-drying in the development of oral drug delivery systems

Abstract

With continual focus on oral drug delivery systems (ODDS), the role of freeze-drying becomes increasingly valuable. While freeze-drying is fundamentally a desiccation process, the advantageous material properties attributed to freeze-drying extend far beyond the preparation of stable pharmaceutical products. The formulation and process variables are important considerations as they affect the final freeze-dried product characteristics. It is of interest to expound on the principles and effects of freeze-drying in the hope of introducing novel products for applications in the development of ODDS. Areas covered: In this review, basic principles, general formulation and process variables associated with freeze-drying will be covered. The application of freeze-drying in 3 areas: modification of active ingredients, development of novel freeze-dried excipients and development of freeze-dried final dosage forms will be discussed. Expert opinion: As a pharmaceutical unit operation, freeze-drying has created new dimensions in the area of oral drug delivery, where the properties of the drugs, excipients and characteristics of the final solid dosage form can be modified by the freeze-drying process. With the emergence of new applications, the role of freeze-drying technology in ODDS is indeed a relevant and promising one.

Orodispersible dosage forms: biopharmaceutical improvements and regulatory requirements

“…In case of poorly water-soluble API, freeze-drying can also aid in achieving a final product with the desired 90 physical or chemical characteristics by reduction of crystal size or the conversion from the crystalline to the 91 amorphous form [7]. Moreover, since low-operation temperature allows to minimize the API thermal 92 degradation, this technology has recently proposed also to develop ODT containing vaccines [8].…”

“…Particle engineering by means of blending [15], co-grinding [16] and freeze-drying [7] allows the design of 122 new multifunctional excipients with improved mechanical or disintegration properties without developing a 123 new chemical entity. As an example, the granulation of a low compressibility saccharide, such as mannitol 124 which provides fast disintegration, with a high compressibility saccharide, such as maltose, produces strong 125 compacts with high tensile strength and fast disintegration time [15].…”

“…Moreover, spray-drying is considered a valuable tool for the development of 129 tableting multifunctional excipients with improved flowability and porosity [12]. Similarly, freeze-drying 130 produces hybrid excipient with high porosity and specific surface area [7]. [20,21].…”

Role of freeze drying technology in the development of orally disintegrating films

“…Effective way of medication and patients care with extreme rapidly. The technique of lyophilization is applicable in the development of Dosage forms that dissolve rapidly, and offer quick dispersion (Siow et al, 2016).…”

“…2015) A freeze-drying has created new dimensions in the area of oral drug delivery system, where the properties of the drugs, excipients and characteristics of the final solid dosage form can be modified. With the emergence of new applications, the role of freeze drying technology in ODDS is relevant and promising (Liew and Odeniyi, Abdelwahed et al, 2015;2006;Siow et al, 2016).…”