Drug-Medical Device Combination Product Design and Quality Control

I.1 Medical Devices and Combination Products

Medical devices are necessary supplies for many medical-surgical processes, such as minor or major surgeries (Muskens et al., 2017). The World Health Organization (WHO) defines a medical device as any instrument, device, material, or implant, intended for a medical purpose. Examples of them are suture threads, gauze, catheters, and cosmetic implants (Benito-Ruiz & Redondo, 2020; Li et al., 2020; McKittrick et al., 2020) . The problem throughout history with these health products is their frequent susceptibility to bacterial colonization and consequently problems in the patient's health, and prolonging patients´ stay in the hospital. For this reason, the development of combined products was born. A combined product, according to the Food and Drug Administration (FDA), is a product that combines or is composed of:

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  Drug and a device.

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  Biological product and device.

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  Drug and biological product.

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  Drug, device, and biological product.

An example of these would be a medical device coated or impregnated with a drug or biological product. These combined products have had a significant trend in recent decades, based on scientific research, and are becoming more and more frequent in the medical device market (Aronson et al., 2020). Examples of these are medical sutures impregnated or loaded with analgesics or antimicrobials to prophylaxis against bacterial contamination or inflammatory processes. Also, the development of catheters with these characteristics is common in the market. These scientific developments would be classified as “drug-device,” combination products. These products are designed from ionizing radiation techniques or impregnation methods. Once designed, they are characterized and used as drug loading and delivery systems. That is why the knowledge of the chemical-pharmaceutical sciences is essential for the design, development, and quality control.

I.2 Pharmaceutical Sciences Today (Drug Delivery Systems)

Currently, research in pharmaceutical sciences is focused on the search for new molecules with therapeutic activity and, in turn, on the development of new controlled drug release systems (Eleftheriadis et al., 2021). The latter is of great interest since it is possible to mediate the session or release of the drug from a pharmaceutical form such as tablets, capsules, emulsions, suspensions, hydrogels, and nanoparticles through external stimuli such as pH, temperature, light, magnetic field, enzymatic activity, and ultrasound. (Eleftheriadis et al., 2021). Mainly nanometric formulations are of great interest. This is due to the ease of permeation through biological membranes. “Nano” formulations, with stimulus characteristics sensitive to temperature and pH, are highly interesting for potential applications for site-specific delivery against cancer. Another essential feature is searching for a drug release system based on biodegradable formulations or polymers. Examples of these polymers are polylactic acid (PLA), polyglycolic acid (PGA), and lactic-co-glycolic acid (PLGA) (Castro et al., 2022). Other biopolymers currently being used due to their high biocompatibility and biodegradability are chitosan, alginate, cellulose, hyaluronic acid, starch, and collagen (Sahu et al., 2021). The control or moderation in drug release tends to be accomplished by using polymers used in the formulation. Likewise, it is essential to mention that an emerging and very relevant trend at the international level is using drugs or biomolecules in medical devices through controlled release (Pino-Ramos et al., 2017). The above is relevant in ​​biomedicine due to the importance of preventing inflammation, pain, and bacterial colonization in patients exposed to medical-surgical procedures (Almalki & Varghese, 2020).