Tuesday, 11 May 2021

Medical Cannabis as a Pharmaceutical: Microbiological Risk and Quality Control



There is a continuing interest in the established and potential therapeutic properties of medical cannabis. These properties are due to cannabinoids, which are a group of compounds present in cannabis. As this interest continues in medicinal cannabis, the quality of medicinal cannabis needs to be strengthened. This means applying a robust microbiological standard. This also means the same standards applied as they would to any other pharmaceutical preparation.

 

This article considers the microbiological aspects; a previous article looked at the analytical methods and outcomes in relation to medicinal cannabis manufacturing (and the first article in this series considered medical and pharmaceutical cannabis products in general). 

 

 

The reference is:

 

Sandle, T. (2021): Medical Cannabis as a Pharmaceutical – Part 3: Microbiological Risk and Quality Control, Journal of GxP Compliance, 25 (1): https://www.ivtnetwork.com/article/medical-cannabis-pharmaceutical-%E2%80%93-part-3-microbiological-risk-and-quality-control

 Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Monday, 10 May 2021

Healthcare IoT Revolutionising Diagnostics Through Digestible Sensors


The Internet of Things (IoT) in healthcare is being used as a new generation of automated medication. Health parameters and vital signs are measured by wearable, embedded, and digestible instruments wherever patients or their caregivers require them. These sensors allow telemedicine and preventive treatment by bringing healthcare to patients' homes.

An article by Supriya Ghuge

A digestible sensor is a device that transmits knowledge about a patient to medical practitioners, allowing them to tailor treatment to the person as well as to other people with related health problems or ailments. Digestible sensors are instruments that incorporate a wireless sensor system into a non-invasive capsule to perform various functions such as calculating pH, strain, or core body temperature data. They are digestible electronic devices, around the size of a drug pill, made of biocompatible materials that include a power supply, microprocessor, controller, sensors, and other components that enable the system to interact for use in the healthcare industry for disease diagnostics and monitoring. Digestible sensors should be a part of the user's body, including new ways to interact with them.

Since the digestible sensors, which look like normal drugs, will execute any of the tasks a doctor usually handles in a routine physical and then some, this device may potentially enable a person to swallow a prescription delivered by their doctor and miss their physical. Digestible sensors will track your bodily processes and wirelessly relay what is going on in your body to another unit, such as your phone or computer, for your own or your doctor's examination. Since they are non-invasive, this real-time healthcare system has far-reaching consequences, far above what existing sensors would do. Digestible sensor technology is the next step after wearable sensors. It is a game-changing technology for illness diagnosis, tracking, and control. As a result, the world of "intelligent pills" is one worth investigating.

How do Digestible Sensors Work?

These tiny digestible sensors communicate with an adhesive pad on the patient's chest via Bluetooth. The real-time data is then transmitted via a smartphone app, which sends the readings to physicians, family members, and caregivers. The advancement of technology is enhancing overall clinical efficacy, addressing issues that have challenged the healthcare industry for decades. The sensor is composed of a computer chip and bacteria that responds by luminescing in response to predefined biomarkers.

The sensors are used to detect the body's actions and physiological reactions through a patch that is applied to the body. In addition, the patch monitors the wearer's heart rate, temperature, movement, and sleep habits. The patch lasts about 7 days and is powered by a battery that lasts about the same amount of time. The user uses a mobile device to view data in detail and assist with treatment. The sensors detect the precise time and type of medication given, and the patient has complete control over this information.

The digestible sensors do not have a battery; instead, they are powered by stomach fluids, and the body sends the sensor's digital signals. The bacteria glows as it encounters markers linked to stomach bleeds, for example. The electronic chip detects the light emission, converts it to a wireless signal, and sends it to a smartphone application. The digestible sensors are made entirely of food ingredients and activate when consumed. These sensors, which imitate sand grains and are made primarily of silicon, are a hybrid of a wearable patch and a digestible sensor that measures physiological data as well as the medicine taken by the user. The transmitted information or medical data allows doctors to tailor the treatment provided to the patient as well as other people with similar health problems or ailments.

Benefits of Digestible Sensors

This system has been tested on patients in clinical trials for several days without causing any significant adverse events or causing any interaction with other medical devices. This breakthrough will assist healthcare professionals in identifying diseases and illnesses early on, as well as wirelessly monitoring patients.

The digestible sensors can also help doctors and patients communicate more effectively. The majority of patient drug errors are caused by ambiguous instructions from their doctor; in these situations, a digestible sensor will be able to warn the doctor that their patient is not taking medicine correctly, obstructing care. As a result, with their widespread use, digestible sensors are expected to reduce the number of deaths caused by drug errors.

Digestible sensors are growing in popularity as a result of their incredible capacity and effectiveness, and their market is rapidly expanding on a global scale. The global digestible sensors market is expected to expand due to the rising prevalence of chronic and lifestyle diseases such as colon cancer, obesity, and gastrointestinal diseases, as well as technological advances in medical devices and increased demand for medication adherence items. Digestible sensors are used in capsule endoscopy, patient tracking, and managed drug delivery applications in the medical field. They alert doctors to drug reactions and patient use of specific medications, resulting in better prescription adherence. These additional benefits have boosted their popularity in the medical sector. Capsule endoscopy has proven to be a reliable and accurate method of endoscopic imaging.

Furthermore, the demand is expected to expand as the population ages, healthcare infrastructure improves, and smartphone use increases. The digestible sensor is a vital healthcare technology that has a positive impact on a variety of clinical areas, including nutrition, hygiene, and fitness. Furthermore, the increasing use of these devices in a variety of industries such as sports, physical fitness, military, and industrial is expected to drive future applications.

Patients with severe mental illnesses (SMI) sometimes fail to follow their drug schedule, which can result in relapse and hospitalization. Despite many measures and drug advancements, high rates of antipsychotic non-adherence remain. The digestible sensors help patients with psychiatric illness and Schizophrenia who are unable to keep track of their drugs or who may even refuse to take them altogether. Digestible Sensors assist nurses and family members in keeping track of their patients' drugs. As a result, the dependable assistance it offers promotes development. 

Challenges and Opportunities Ahead

Conversely, the demand is being hampered by a lack of knowledge about the benefits of digestible sensors, as well as physician scepticism. Furthermore, the growth of digestible sensors is expected to be limited by the difficulty of production and high manufacturing costs, as well as uncertain regulatory policies. Nonetheless, technological advances, combined with an increasing number of pharma companies capable of mass-producing digestible sensors, are expected to lower production costs, supporting the growth of the digestible sensors market over the foreseeable future.

The idea of implanting tiny microchips and cameras into people's bodies may make some people uneasy. Numerous scientific, legal, and ethical issues will undoubtedly be posed in the coming years. Questions regarding anonymity, data sharing, and side effects continue to be posed, so the verdict is still out. Pharmaceutical companies and regulatory agencies must adhere to strict safety guidelines. The sector must also overcome the enormous challenge of large product development costs, as these innovations necessitate the invention of new integrated technologies, a problem that could delay development. Nonetheless, the data collected through this easily digestible technology has a tremendous potential for shedding light on newly discovered gut functions.

Researchers do not yet have a complete understanding of how gastric juices, electrolytes, hormones, and other gut metabolites work together to maintain gut health. As a result, we can confidently predict that these highly integrated digestible sensors will be the way of the future for our gut health.

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Sunday, 9 May 2021

New method to distinguish between viral and bacterial infections


 

When patients complain of coughing, runny nose, sneezing and fever, doctors are often stumped because they have no fundamental tool to identify the source of the respiratory symptoms and guide appropriate treatments.

 

That tool might finally be on its way. In a study proving feasibility, researchers at Duke Health showed that their testing technology can accurately distinguish between a viral and a bacterial infection for respiratory illness - a critical difference that determines whether antibiotics are warranted. And, importantly, the test provided results in under an hour.

 

Researchers have developed a gene expression method that diverges from current diagnostic strategies, which focus on identifying specific pathogens. The current tests are time-consuming and can only identify a pathogen if it's specifically targeted by the test in the first place.

 

Host gene expression, however, looks for a distinct immune signal that is unique to the type of infection the body is fighting. The immune system activates one set of genes when fighting bacterial infections and a different set of genes in response to a viral infection. After the team discovered these gene expression signatures for bacterial and viral infection, they collaborated with BioFire Diagnostics, a company that specializes in molecular diagnostics, to develop this first-of-its kind test.

 

See:

 

Ephraim L. Tsalik, et al. Discriminating Bacterial and Viral Infection Using a Rapid Host Gene Expression TestCritical Care Medicine, 2021; Publish Ahead of Print DOI: 10.1097/CCM.0000000000005085

 

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

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