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Previously, we developed a novel technology to foam hot and molten dispersions at atmospheric pressure with a rotor–stator homogenizer that is suitable for exploiting the advantages of low-density forms.
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To date, melt-based formulations have been promising new technologies to produce low-density gastroretentive drug delivery systems. There are countless possibilities to develop low-density drug carriers that are able to float on the top of gastric fluid and remain in the stomach until total erosion. In the case of expanding devices, the size increases up to 1.2 cm, inhibiting the transit of the sample to the colon. They usually contain a mucoadhesive polymer such as alginate, chitosan, or even polyethylene glycol. Mucoadhesive formulations contain adhesive biopolymers that adhere to the mucosa of the stomach’s inner wall and release an active pharmaceutical ingredient (API).
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Several technologies are currently available to succeed gastric retention. In the case of many antiviral agents, such as zidovudine, acyclovir, or lamivudine, better efficacy has been described with gastroretention, and some of these are also available as registered products. Due to the better bioavailability by gastroretention, more successful therapy and faster remission can be achieved for some diseases and infections. One of the most important challenges today is antibiotic resistance and protection against various viruses such as COVID-19. The bioavailability of active ingredients that have an absorption window on the upper part of the GI can be enhanced by formulating gastroretentive dosage forms. Several drugs have poor oral bioavailability due to low or incomplete absorption in the GI. The pH varies in different parts of the digestive tract, and motility depends on meals, as well as enzyme activity. The physiological variability of the gastrointestinal tract (GI) creates serious challenges for the development of oral drug delivery system formulations. They have various advantages, such as good compliance and low costs for storage and transport, and various forms can be manufactured. Oral drug delivery systems are the most common dosage forms. According to our experiments, a stable foam could be produced by rapid homogenization (less than 1 min) without any surfactant material. The prolonged drug release and mucoadhesive properties were proved in a pH 1.2 buffer. The density of the molded solid foam was studied by the pycnometer method, and its structure was investigated by SEM and micro-CT. This matrix was melted at 54 ☌ in order to produce a dispersion of active substance and was foamed by different gases at atmospheric pressure using an ultrasonic homogenizer. Matrix components, PEG 4000 and stearic acid type 50, were selected with the criteria of low gastric irritation, a melting range below 70 ☌, and well-known use in oral drug formulations. Our aim was to produce a stable floating formula by foaming. Low-density floating formulations can also increase the gastric residence time of drugs therefore, drug release will be sustained. These special dosage forms can result in increased bioavailability of drugs. Although foams are promising dosage forms in the pharmaceutical industry, their usage is not prevalent due to decreased stability of the solid foam structure. Solid foams are not only used in the aerospace field but also in everyday life. In recent years, the application of solid foams has become widespread.