Abstract:Drug hydrolytic degradation, caused by atmospheric and inherent humidity, significantly reduces the therapeutic effect of pharmaceutical solid dosages. Moisture barrier film coating is one of the most appropriate and effective approaches to protect the active pharmaceutical ingredients (API) from hydrolytic degradation during the manufacturing process and storage. Coating formulation design and process control are the two most commonly used strategies to reduce water vapor permeability to achieve the moisture … Show more
“…Organic solvent-based film coating: Although the use of organic solvent is not preferred, film coating with hydrophobic or lipophilic polymers requires the use of organic solvents due to the low aqueous solubility of coating materials. The highly hydrophobic polymers are beneficial as moisture-protective coating polymers as they can reduce the water vapor permeability of the final film by preventing the movement of water molecules [ 9 ]. In addition, coating process using organic solvents can also reduce drug degradation by hydrolysis.…”
Section: Film Coating Methodsmentioning
confidence: 99%
“…Therefore, organic solvent-based coating is useful for moisture sensitive drugs. The rate of evaporation of the solvent is crucial for the quality of final product and many variables including temperature, atmospheric pressure, and air movement should be adjusted to optimize the evaporation rate [ 9 ]. Despite of pharmaceutical needs, organic solvent-based coating has many critical limitations because of potential toxicity of residual solvents, flammability, and environmental safety issues [ 10 ].…”
Tablet film coating is a common but critical process providing various functionalities to tablets, thereby meeting diverse clinical needs and increasing the value of oral solid dosage forms. Tablet film coating is a technology-driven process and the evolution of coated dosage forms relies on advancements in coating technology, equipment, analytical techniques, and coating materials. Although multiple coating techniques are developed for solvent-based or solvent-free coating processes, each method has advantages and disadvantages that may require continuous technical refinement. In the film coating process, intra- and inter-batch coating uniformity of tablets is critical to ensure the quality of the final product, especially for active film coating containing active pharmaceutical ingredients in the coating layer. In addition to experimental evaluation, computational modeling is also actively pursued to predict the influence of operation parameters on the quality of the final product and optimize process variables of tablet film coating. The concerted efforts of experiments and computational modeling can save time and cost in optimizing the tablet coating process. This review provides a brief overview of tablet film coating technology and modeling approaches with a focus on recent advancements in pharmaceutical applications.
“…Organic solvent-based film coating: Although the use of organic solvent is not preferred, film coating with hydrophobic or lipophilic polymers requires the use of organic solvents due to the low aqueous solubility of coating materials. The highly hydrophobic polymers are beneficial as moisture-protective coating polymers as they can reduce the water vapor permeability of the final film by preventing the movement of water molecules [ 9 ]. In addition, coating process using organic solvents can also reduce drug degradation by hydrolysis.…”
Section: Film Coating Methodsmentioning
confidence: 99%
“…Therefore, organic solvent-based coating is useful for moisture sensitive drugs. The rate of evaporation of the solvent is crucial for the quality of final product and many variables including temperature, atmospheric pressure, and air movement should be adjusted to optimize the evaporation rate [ 9 ]. Despite of pharmaceutical needs, organic solvent-based coating has many critical limitations because of potential toxicity of residual solvents, flammability, and environmental safety issues [ 10 ].…”
Tablet film coating is a common but critical process providing various functionalities to tablets, thereby meeting diverse clinical needs and increasing the value of oral solid dosage forms. Tablet film coating is a technology-driven process and the evolution of coated dosage forms relies on advancements in coating technology, equipment, analytical techniques, and coating materials. Although multiple coating techniques are developed for solvent-based or solvent-free coating processes, each method has advantages and disadvantages that may require continuous technical refinement. In the film coating process, intra- and inter-batch coating uniformity of tablets is critical to ensure the quality of the final product, especially for active film coating containing active pharmaceutical ingredients in the coating layer. In addition to experimental evaluation, computational modeling is also actively pursued to predict the influence of operation parameters on the quality of the final product and optimize process variables of tablet film coating. The concerted efforts of experiments and computational modeling can save time and cost in optimizing the tablet coating process. This review provides a brief overview of tablet film coating technology and modeling approaches with a focus on recent advancements in pharmaceutical applications.
“…Since, water-soluble polymers do not influence therapeutic effect or drug release, thus widely employed in moistureprotective coating 31 , while some could be used for tastemasking coating and can be easily used in AFC process 20 .…”
The presentation of this work aims to update professionals involved with aqueous film coating (AFC) of pharmaceuticals on facts associated with film coating (FC) based on aqueous solvent (AS). Initially sugar coating (SC) was the first choice of pharmaceutical industry and much time and efforts were spent in perfecting the techniques and processes of SC. Long processing time and demand for operator skill as in SC compelled them to develop FC. The FC of substrate is achieved by spraying solution of diverse polymer in AS or volatile organic solvent (VOS). Initially, use of VOS in the FC is preferred over AS, as latter inherits problems like sticking, picking, over-wetting, and many more. Momentum for using AS based FC and replacing the VOS based one with the aqua based one got accelerated from last few decade for reasons like safety, toxicity, stricter regulation on environmental pollution, and economy. Nowadays coating techniques & process relies mostly on AS due to its significant benefits over VOS. Functional properties of the film-coated pharmaceuticals depends greatly on film forming polymer (FFP) along with other factors like process, equipment, technology, additives, and many others. Summarised information on technical aspect of AFCs is rare, necessitating this work. Thus information gathered, summarised, studied, and hereby is attempting to be presented in a convenience way for enriching stakeholders in the pharmaceutical field. The presentation is for updating professionals in this regard.
Key words: Aqueous, dispersion, film-coating, latex, polymer.
“…Lipophilic films are generally applied onto the skin to exploit their moisture barrier properties [ 50 ]. Due to their nonpolar nature, the incorporation of a lipid into a polymeric film can make it even more lipophilic [ 51 ].…”
The use of lipids in the composition of polymeric-based films for topical administration of bioactive ingredients is a recent research topic; while few products are commercially available, films containing lipids represent a strategic area for the development of new products. Some lipids are usually used in polymeric-based film formulations due to their plasticizing action, with a view to improving the mechanical properties of these films. On the other hand, many lipids have healing, antimicrobial, anti-inflammatory, anti-aging properties, among others, that make them even more interesting for application in the medical-pharmaceutical field. This manuscript discusses the production methods of these films both on a laboratory and at industrial scales, the properties of the developed biopolymers, and their advantages for the development of dermatologic and cosmetic products.
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