Wednesday, 8 April 2020

EU GMP Annex 1 - The new draft and implications for sterile product manufacturers


EU GMP Annex 1 is the primary document governing the manufacture, control and release of sterile pharmaceutical products (both terminally sterilised and aseptically filled medicines). The Annex will shortly undergo a comprehensive update, as signalled by a new draft issued in February 2020. This white paper assesses many of the key points within the draft, focusing on those areas that have a direct impact upon sterile product manufacturing.

Tim Sandle has authored a white paper on this subject:

Sandle, T. (2020) EU GMP Annex 1 - The new draft and implications for sterile product manufacturers, White Paper 1, Reading Scientific Services Ltd, UK

The key takeaways from the latest draft are:

• The expectation for each facility to have in place a formal, holistic contamination control strategy, focused on minimising contamination control with respect to sterile manufacturing
• Additional requirements for cleanroom classification (beyond ISO requirements)
• A major focus on risk-based approaches
• Recommendations for the wider use of barrier technology
• A strong focus on personnel controls, such as gowning, and training

This white paper provides an overview of the draft Annex 1 and considers the focal points for sterile products manufacture, control and release.

To access go to: Annex 1

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

Tuesday, 7 April 2020

ICH Q12 Technical and regulatory considerations for pharmaceutical product lifecycle management


New guidance from the EMA has been published in March 2020. This guideline provides a framework to facilitate the management of post-approval Chemistry, Manufacturing and Controls (CMC) changes in a more predictable and efficient manner.  A harmonised approach regarding technical and regulatory considerations for lifecycle management will benefit patients, industry, and regulatory authorities by promoting innovation and continual improvement in the pharmaceutical sector, strengthening quality assurance and improving supply of medicinal products.


The focus is with pharmaceutical drug substances (APIs) and products (both chemical and biological) that require a marketing authorization; drug-device combination products; and with analytical methods.



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

Monday, 6 April 2020

Pharmaceutical Microbiological Quality Assurance and Control: A guide for non-sterile manufacturing


A new book of interest has been published: Pharmaceutical Microbiological Quality Assurance and Control: A guide for non-sterile manufacturing, edited by David Roesti and Marcel Goverde

Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals.

Pharmaceutical Microbiological Quality Assurance and Control offers a thorough and practical guide for professionals working in the field of non-sterile drug manufacturing. Drawing on the authors' experience working in the field, the book contains a thorough and up-to-date approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Comprehensive in scope, the book covers state-of-the-art microbiology quality assurance and control (QA / QC) tests as well as risk mitigation strategies.

The book is designed so that professionals can implement the methodologies presented in a facility or laboratory to meet current microbiology manufacturing best practices. In addition, the authors (noted experts on the topic) discuss developments in microbiological testing technology. The authors have years of experience practicing microbiological QA/QC in large multinational pharmaceutical companies and therefore present real-life complex cases involving tough decision-making.

I am please to have contributed a chapter:

Sandle, T. (2020) Utilities Design and Testing. In Roesti, D. and Goverde, M. (Eds.) Pharmaceutical Microbiological Quality Assurance and Control: A guide for non-sterile manufacturing, Wiley, USA, pp189 - 230

The book is available from Amazon.

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

Sunday, 5 April 2020

New research outlines advice for coping with acne


Acne is a common skin condition, affecting people at different ages, and one that can wreak havoc with your self-esteem and often appears at the worst possible time. New research identifies some strategies for dealing with the condition.

To help to increase the knowledge around the condition of acne, the website eMediHealth has completed an in-depth survey about the skin condition acne. To arrive at the findings, 64 dermatologists participated in the research (including those based in the U.S., U.K. Canada and Australia). The research output reveals some interesting facts about acne, as well as common mistakes people make while attempting to deal with the condition.

Acne vulgaris refers to a long-term skin disease, which arises when hair follicles become clogged with dead skin cells and oil from the skin. There is also a probable association with the anaerobic bacterium Cutibacterium acnes, in that increased sebum production creates an environment that can sustain the colonization of the bacterium. The condition is often a source of discomfort for people and it is connected with mental health issues, such as low self-esteem.

Why acne occurs

The research produced a number of interesting findings about acne. The first relates to the most common skin type associated with the condition. Here the overwhelming majority (92.1 percent) of the dermatologists connected the condition to oily skin. This is because those with oily skin tend to have overactive oil glands that produce excessive sebum.

As to why certain people have a tendency to develop acne, hormonal imbalance was stated to play a major role in the development of acne and was identified as the top trigger for acne, Other causative factors were identified as high levels of stress and excessive sugar intake.
However, other factors that have been commonly associated with the development of acne, like smoking (20.31 percent), pollution (17.18 percent), and dust (7.81 percent), were rated low by the experts.

In terms of the after-effects of acne, more than half (55 percent) of the participants in the study held the view that the risk of scarring largely depends on the type of acne, and 28 percent believed that it depends on both the type of acne and the medication used to treat it. Generally, inflammatory acne is viewed as more likely to lead to scarring compared with non-inflammatory acne.


Dealing with acne

In terms of strategies for dealing with acne, ensuring that all make-up is thoroughly removed was found to be important. With this issue, 70.31 percent of the dermatologists emphasized the importance of removing every trace of makeup before a person with acne goes to bed. This is necessary so that the skin can breathe easily while the person sleeps.

Another factor to take into consideration for minimizing acne relates to skin cleaning. 78.13 percent cited that excessive skin cleaning, along with scrubbing, represents a common mistake made by patients with acne.

Where acne is severe, the dermatologists stressed the importance of seeking advice. With this issue, 79.69 percent said that too many patients with acne usually make the error of not seeking dermatological help, which can worsen their condition.

With standard acne treatments, isotretinoin and retinoids (medications that are derived from vitamin A) emerged as clear favorites among the dermatologists, each registering 75 percent of the votes.
As a word of warning for those with acne considering self-medicating, the overall effectiveness of home remedies for acne was deemed to be low. This means those looking for quick solutions through unverified treatments or remedies should take care. A total of 46.88 percent of the dermatologists stated that none of the ‘alternative’ remedies are likely to yield any significant results, and only 3.13 percent felt that the listed acne remedies may be helpful in some way.

Of these alternatives, witch hazel topped the list with 17.9 percent of the votes, followed by essential oils, which were recommended by 15.63 percent of the respondents.

For people with mild acne, the advice is to speak to a pharmacist or seek advice from a dermatologist about the appropriate medicines to treat it. For those with severe acne, advice from a medical practitioner should be sought.

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

Saturday, 4 April 2020

Electronic product information (ePI) for human medicines


The European Medicines Agency has issued a new guidance document covering digital data.

ePI in the EU for all human medicines, including both centrally and nationally authorised medicines, will be created using a common electronic standard. The following definition of a common EU electronic standard for ePI is proposed:

A common standard for ePI in the EU refers to the technical features of ePI (including mark-up language, controlled vocabularies and interoperability specifications) agreed by EMA, HMA, NCAs, EC, and representatives of the pharmaceutical industry, patients and HCPs. The standard will be used to generate ePI that fulfils the agreed key principles.

The new document is a joint EMA–HMA–EC collaboration arising from a workshop held at EMA on 28 November 2018 that brought together patients / consumers, Health Care Professionals, the pharmaceutical industry, academia, not-for-profit organisations and regulators to discuss stakeholder needs and concerns, give an overview of the main ePI initiatives ongoing in the EU and decide how to move forward with a common approach.


The outcome of the workshop was a draft proposal for ‘key principles’ for ePI. These key principles were the subject of a 6-month public consultation (from January 31, 2019 until July 31, 2019).

Following the consideration of submissions received during the public consultation, the key principles were updated. They now represent EMA-HMA-EC guidance on ePI and form the basis of follow-up implementation plans for ePI.

For further details see: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/electronic-product-information-human-medicines-european-union-key-principles_en.pdf

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

Friday, 3 April 2020

Shorter Regimen for Preventing TB Found to Have Lasting Protective Effect in People Living with HIV


A new study finds a single course of weekly rifapentine and isoniazid for three months (3HP) provides lasting protection against tuberculosis (TB) and does not need to be repeated year after year. The WHIP3TB trial, led by the Aurum Institute and partners, was presented today at the Conference on Retroviruses and Opportunistic Infections (CROI). The clinical trial showed that repeat annual administration of 3HP did not provide additional benefits when compared to the single, three-month treatment course. The trial involved over 4,000 adults with HIV infection receiving antiretroviral therapy (ART) across three African countries.

“We knew that 3HP was as effective as longer treatments for preventing TB disease in people with HIV, but there were doubts about the duration of protection in high-burden TB settings,” said Gavin Churchyard, group CEO of the Aurum Institute and principal investigator on the study. “What this study demonstrates conclusively is that there is no need to repeat a course of 3HP annually, a finding that has huge implications for health programs caring for millions of people with HIV globally.”

The study was led by the Aurum Institute and sponsored by the KNCV Tuberculosis Foundation and funded by USAID through the Challenge TB project. The WHIP3TB trial was implemented by the Aurum Institute and Perinatal HIV Research Unit (PHRU) in South Africa, the Ohio State University, Global One Health initiative in Ethiopia, and by Centro de Investigação de Saúde de Manhiça (CISM) in Mozambique. Other senior investigators were from the London School of Hygiene and Tropical Medicine and Johns Hopkins University Center for TB Research.

The study had two parts. The first part compared the effects of a single three-month course with two three-month courses given annually (for two years) to people living with HIV. The second arm compared 3HP to daily isoniazid for six months. Researchers enrolled 4,027 adults with HIV (and on ART) but without active TB and divided them into three groups: one group received 3HP for three months, another received 3HP for three months in year one and again in year two, and another received daily isoniazid for six months. After two years of follow up, rates of TB were virtually the same in participants who received either one (three-month) course or two (three-month) courses of 3HP. The 3HP regimen was found to be safe, with similarly low rates of adverse effects in both 3HP arms of the trial.

After one year, the researchers found adherence to be higher among patients who were assigned to the 3HP groups than among patients who were prescribed six months of isoniazid. Completion of the treatment course in the combined 3HP arms (3610 people) versus isoniazid (404 people) arms was 90.4% versus 50.5%, respectively.

“When we’re asking people who are not sick to take medicines, adherence can be a huge problem,” said Professor Katherine Fielding, from London School of Hygiene & Tropical Medicine and senior statistician on the study. “This study confirms what we already suspected—that it’s easier for people to take pills once a week, for three months, than once a day for six months. Shorter regimens lead to higher adherence, which ultimately improves treatment outcomes.”

TB Prevention

Tuberculosis, a disease that still kills around 1.5 million people every year, can lie dormant for decades before it strikes; this is called “latent TB infection.” People with latent infection—almost a quarter of the globe—have no TB symptoms, are not contagious, and most of them don’t know they are infected. If left untreated, latent infection can develop into active TB, the form of TB that makes people sick and is capable of being transmitted from one person to another.

“Latent TB infection is the breeding ground for the TB epidemic, and preventing new cases is critical if we want to end the TB epidemic,” added Churchyard.

People living with HIV are at high risk of developing TB and are 20 to 37 times more likely to move from latent infection to active TB. Treatment of TB infection is referred to as TB preventive therapy (TPT) and is one of the most powerful ways to prevent TB. At the United Nations High-Level Meeting on Ending Tuberculosis in September 2018, heads of states committed to providing preventive treatment to at least 30 million people, including 6 million people living with HIV by 2022. That year, only 65 countries had reported initiating 1.8 million people living with HIV (PLHIV) and 349,487 children < 5 years on isoniazid preventive therapy (IPT).

“The fact that there is no need for a repeat dose of the medicines is good and timely news for all patients receiving 3HP as well as for public health practitioners,” said Dr. Gidado Mustapha, director of Challenge TB and head of the project management unit at the KNCV Tuberculosis Foundation .

The 3HP regimen offers a shorter, safer alternative to the older standard of care (IPT) in which people take isoniazid every day for between six and 36 months. In February 2018, the World Health Organization (WHO) released consolidated guidelines for the treatment of latent TB infection that recommend the use of 3HP for people living with HIV and people who are in close contact with TB cases.

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

Thursday, 2 April 2020

World Pharmacopoeias move towards increased global co-operation


At the 11th International Meeting of the World Pharmacopoeias (IMWP) co-hosted by the WHO and the EDQM in Strasbourg (France), national and regional pharmacopoeias brought forward initiatives to strengthen their co-operation as a way to improve public health outcomes for patients.

Following up on discussions which had taken place at the 10th IMWP, a new framework for exchanging information between the Pharmacopoeial Discussion Group (PDG) and the IMWP was presented by the PDG. The IMWP participants welcomed the proposal and agreed to run a one-year pilot phase to test this new framework, which is expected to facilitate exchanging information and lays out new ways and modalities for co-operation.

Pharmacopoeias shared an update on their respective responses to the N-nitrosamine contamination in medicines. This exchange which was initiated at the 10th IMWP was found very helpful to facilitate alignment of action to be taken by the different pharmacopoeias in support of decisions by regulatory authorities.

Participants re-emphasised the importance of exchanges between the world pharmacopoeias and agreed to meet more frequently by adding regular virtual meetings in addition to the annual face-to-face meetings.

Read more in the press release

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

Wednesday, 1 April 2020

Degree of coloration of liquids


The European Pharmacopoeia Commission has adopted a new version of one of its widely used general methods, chapter 2.2.2. Degree of coloration of liquids, which has been extensively revised to include the instrumental method. The revised chapter will be published in European Pharmacopoeia (Ph. Eur.) Supplement 10.3, available in July 2020 (implementation date: 1 January 2021).

This chapter now describes three methods:
  • in method I (visual method), the colours are compared in diffused daylight, viewing horizontally against a white background;
  • in method II (visual method), the colours are compared in diffused daylight, viewing vertically against a white background;
  • method III is the instrumental method – this part of the text has been harmonised with the USP and the JP in the Pharmacopoeial Discussion Group (PDG).
Instrumental methods for measurement of colour provide more objective data than the subjective viewing of colours by a small number of individuals. With adequate maintenance and calibration, they can provide accurate, precise and consistent measurements of colour that do not drift over time. Through extensive colour-matching experiments involving human subjects with normal colour vision, distribution coefficients (weighting factors) have been established for each wavelength in the visible spectrum, giving the relative amount of stimulation of each receptor type caused by the light of that wavelength.

At present, however, the specifications indicated in the Ph. Eur. are all based on visual determination and an exact correlation between visual and instrumental results is not always possible, depending on the ability of the analyst to differentiate between colour grades (visual method) and on the equipment settings. Hence, when using chapter 2.2.2, the analyst is asked to report the results together with the method used: method I, II or III.

The instrumental method, when used instead of one of the visual methods currently prescribed in individual monographs, is nevertheless considered to be an alternative method and, as such, its use must meet the requirements of the Ph. Eur. General notices, which state: “the tests and assays described are the official methods upon which the standards of the Pharmacopoeia are based. With the agreement of the competent authority, alternative methods of analysis may be used for control purposes, provided that the methods used enable an unequivocal decision to be made as to whether compliance with the standards of the monographs would be achieved if the official methods were used. In the event of doubt or dispute, the methods of analysis of the Pharmacopoeia are alone authoritative.”
Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)

Tuesday, 31 March 2020

EU GMP Annex 1: What The ‘Final’ Draft Reveals


A new paper reviews the new draft of EU GMP Annex 1. In doing so the focus is on those aspects that are different to the 2017 draft, rather than spending much time comparing the 2020 draft with the current Annex 1 (which is dated 2009).

The review includes an overview of the core changes, which include:

The global acceptance and implementation of ICH Q9 (Quality Risk Management)  and Q10 (Pharmaceutical Quality System), is not reflected in the current Annex. The new draft contains many references to Quality Risk Management (QRM) in particular, emphasizing that QRM should be used as a proactive tool. There are now 92 instances of the word “risk” in the new draft, an increase from 20 in the previous version.

There have been advances in sterile manufacturing technology, especially with RABS and isolators. There have also been advances with rapid microbiological methods, which the draft Annex acknowledges.

There was some ambiguity with the current version and these needed correction or clarification.

Annex 1 is often beyond sterile manufacturing, including aspects of non-sterile manufacturing. The scope of the new draft has been modified to reflect this.

There is the requirement for a formal, holistic contamination control strategy (which is now abbreviated to ‘CCS’ in the new draft). The expectation now appears to be for a formal document which reflects the site-wide strategy for minimizing contamination control with respect to sterile manufacturing .


The requirements of the contamination control strategy have been widened (43 mentions, up from 19 in the 2017 draft), however, with the new draft, extending to the need to fully-understand and review design, procedural, technical and organizational controls.

The reference is:

Sandle, T. (2020) EU GMP Annex 1: What The ‘Final’ Draft Reveals, Journal of GXP Compliance, 24 (2): 1-15, at: https://www.ivtnetwork.com/article/eu-gmp-annex-1-what-%E2%80%98final%E2%80%99-draft-reveals

For details, contact Tim Sandle

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

Monday, 30 March 2020

Guide to sterility test isolators


An isolator is an arrangement of physical barriers that are integrated so that the workspace (an enclosed environment) within the isolator is sealed from the outside environment. Isolators provide a testing environment free from contamination, through routine sanitization using a validated cycle and confirmed by environmental monitoring.

In addition, these devices enable the isolation between the operator and the process. There are many complications with isolators, from design to qualification, and with general operation.

It certainly remains that isolators cannot prevent contamination caused by GMP deficiencies such as poor aseptic procedures and inadequate training of operators.

To address these concerns and to outline best practices, Tim Sandle has written a new Pharmig guide:

Sandle, T. (2019) Guide to sterility test isolators, Pharmig, Stanstead Abbotts: UK (ISBN 978-0-9560804-9-3)

Foe details see: https://www.pharmig.org.uk/en/products/publications/

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

Sunday, 29 March 2020

Qualification of GC Equipment


EDQM has posted new guidance on the qualification of gas chromatography equipment.

The document is the second Annex of the core document “Qualification of Equipment”, and it should be used in combination with it when planning, performing and documenting the GC equipment qualification process.

The core document contains the general introduction and the Level I and II of qualification, common to all type of instruments, and the present annex contains GC instrument-related recommendations on parameters to be checked and the corresponding typical acceptance limits, as well as practical examples on the methodology that can be used to carry out these checks.

Level III (Periodic and motivated instrument calibration/checks) and IV (In-use instrument checks) qualifications must be carried out as an ISO 17025 requirement.

The tests proposed in the Level III and IV of qualification are based on an overall approach, in which several parameters are checked at the same time in a combined test procedure, to obtain information on the overall system performance (e.g. peak area precision, retention time precision, temperature programme reproducibility, etc). Nevertheless, it should be noted that it is also acceptable to check these parameters individually by using other well-defined procedures.

Requirements and (if applicable) corresponding typical acceptance limits (given in bold) should be applied; however other appropriately justified approaches are acceptable. Exemplary procedures provided in this document have non-binding character. They can be helpful when carrying out the required qualification.

Nevertheless, it is left to the professional judgement and background experience of each OMCL to decide on the most relevant procedures to be undertaken in order to provide evidence that their GC systems are working properly and are suitable for their intended use. If the qualification of equipment is done by the manufacturer or an external service provider, it is the responsibility of the OMCL to make sure that this is in line with the requirements set out in this guideline.

For details, see EDQM

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

Saturday, 28 March 2020

Update for testing for particulate contamination


At its 165th session in November 2019, the European Pharmacopoeia Commission adopted two general chapters related to testing for particulate contamination in pharmaceutical preparations.

The revisions to general chapter 2.9.19. Particulate contamination: sub-visible particles supplement the Pharmacopoeial Discussion Group (PDG) harmonised text with alternative local requirements applicable to biological parenteral preparations. Such preparations are provided in low volumes and the local requirements – marked in the text with white diamonds – allow testing of these and other preparations to be performed using volumes smaller than 5 mL where suitable instrumentation is available. The PDG remains committed to further revising the chapter in order to integrate these changes into the harmonised text.

The new, non-mandatory general chapter 5.17.2. Recommendations on testing of particulate contamination: visible particles provides information on visual inspection and control of visible particles in liquid preparations for which testing according to the general chapter 2.9.20. Particulate contamination: visible particles applies. The text highlights the different sources of foreign particle contamination of liquid preparations and the fact that every effort should be made to avoid their presence. Consideration is given to the different inspection stages during production and quality control, including stability testing. Acceptable quality level (AQL) testing (with reference to ISO standard 2859-1) following a 100% inspection of the batch is also addressed. This chapter is not intended to elaborate on GMP requirements, but rather should be read in conjunction with them. Detection of visible particles in parenteral products is probabilistic in nature and the occurrence of particles is random. The chapter therefore provides guidance on how users can establish that their product is “practically free from particles”.

These two chapters will be published in European Pharmacopoeia (Ph. Eur.) Supplement 10.3 and will become effective on 1 January 2021.


For further details see: Ph. Eur.

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

Friday, 27 March 2020

Gut Microbiome Samples Head for Space


Los Alamos National Laboratory scientists Armand Dichosa and Anand Kumar have sent samples of the human gut microbiome into space tonight, part of a project with NASA, DTRA and Rhodium Scientific.

On its 11:50 p.m. March 6 launch, SpaceX-20 they carried these samples to the International Space Station National Laboratory where they will be allowed to grow in order to understand the effect microgravity has on the microbial community. The samples have been carefully prepared at Los Alamos so that for each sample there is a complementary sample staying here on Earth.

Genomics Investigation of Human Gut Microbiome to Determine Effects of Microgravity Exposures (Rhodium Space Microbiome) examines the effects of spaceflight on the human gut microbiome, a complex community of numerous bacterial species. Developing a better understanding shifts in microbiome diversity and function and how they affect human health and performance may help protect people on future missions. Recent studies have shown a connection between alterations in the structure and function of the gut microbiome and multiple chronic and acute diseases.
Upon return, both sets of samples will be sequenced and analyzed to identify genetic changes that might occur to the bacterial communities, and to understand the potential implications these changes may have to human health in microgravity.

NASA has a video of the live-stream the March 6 launch at 11:50 p.m. Eastern Time

See: More information on the experiment

Also check-out:

Social Media handles - 

#LosAlamosNatLab
#BusinessOfScience
#SpaceMicrobiome

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

Thursday, 26 March 2020

CBD: It's (Biologically) More Intricate Than You Think

Image Source: Unsplash
In many ways, the hemp plant is intertwined with the history of the United States. British settlers even brought a store of hemp seeds along during their journey across the Atlantic and were “compelled by law to grow hemp.” Today, we understand that hemp has numerous medical benefits, but during colonial times, hemp was primarily used in textile and fiber-based applications, at least until 1937.

A guest post by Indiana Lee
That year, Congress passed the Marihuana Tax Act, which effectively made hemp cultivation a crime. At the time, hemp was considered dangerous, lumped in with its cousin marijuana, which has psychoactive effects when ingested or smoked. Yet the hemp plant contains only trace amounts of tetrahydrocannabinol (THC), the cannabinoid that’s responsible for a marijuana user’s “high.”

While, as the most notorious of the estimated 113 cannabinoids found in the cannabis plant, THC gets the bulk of press surrounding the plant, it’s not necessarily the star of the show. For instance, cannabidiol, commonly known as CBD, doesn’t induce euphoria but has shown promise in treating a wide variety of health conditions, from anxiety and insomnia to Alzheimer’s and neurodegenerative disorders.

For this reason, and thanks to the 2018 passage of the Hemp Farming Act of 2018 (H.R.5485), which re-legalized hemp cultivation at the federal level, CBD shops are popping up in strip malls and co-ops across the country. We still have more to learn about CBD, however, and consumers should note that not all products containing CBD are consistently effective.

Like its cousin marijuana, the cellular makeup of hemp can vary considerably between strains, resulting in differing effects depending on an individual's condition and the plant’s potency. In effect, the idea of “CBD” has been oversimplified for the masses, but it’s much more complex than meets the eye.

Cannabis Legalization and Terminology

Fast forward to the 21st century, where, after decades of prohibition, the hemp industry is once again booming. The passage of H.R. 5485 paved the way towards a greater understanding of and research on the ways in which hemp affects the body. (It’s important to note that hemp cultivation is still banned in Idaho and South Dakota.) To be considered “hemp,” a cannabis plant can contain no more than 0.3% THC.

When it comes to medical marijuana, CBD takes center stage as the plant’s most helpful cannabinoid. Derived directly from hemp, CBD interacts with your body’s endocannabinoid system (ECS). According to a 2017 study published on ScienceDirect, the ECS is “involved in many physiological regulation pathways in the human body,” such as mood, memory, appetite, and pain sensations.

ECS receptors and neurotransmitters are lipid-based, which is why CBD extract is often housed in some type of oil for greater effectiveness. The two primary ECS receptors are CB1 and CB2, and THC easily binds to both receptors. CBD, on the other hand, interacts with the ECS in a slightly different manner: The cannabinoid acts as a sort of influencer, modifying a receptor’s ability to bind to other cannabinoids.

Yet cannabinoids don’t work alone when it comes to effects on the body. The hemp plant contains a number of other components that may help determine treatment efficacy, such as terpenes. Like cannabinoids, terpenes are developed in the trichomes of the hemp plant, and are primarily responsible for producing the unique scent of a particular strain. Terpenes also play a role in a plant’s medicinal effects. For example, the limonene terpene (also found in lemons) may improve mood and reduce anxiety. 

Efficacy and Medical Uses for CBD

Reducing anxiety, in fact, is one of the most lauded effects of CBD. Studies indicate that CBD may directly activate the 5-HT1A serotonin receptor, inducing anti-anxiety and antidepressant effects. Therefore, CBD could ultimately replace a number of pharmaceutical medications, many of which come with negative side effects and may be addictive.

For its part, CBD is considered non-addictive and may also help with pain relief. To wit, researchers have proposed the use of CBD as an alternative to opioids for managing chronic pain. Opioid misuse has become a scourge on society in recent years, and preliminary data indicates that “opioid overdoses and abuse have been significantly lower in states that have legalized cannabinoids,” writes the Psychiatric Times. However, that data is in dispute, and more research is needed.

For now, we can at least focus on the proven benefits of CBD, including the reduction of seizure frequency on some patients. According to the American Epilepsy Society, CBD has been shown to reduce seizures among patients with treatment-resistant epilepsy, but CBD treatment effectiveness may wane over time, requiring higher doses. CBD works against seizures by conferring neuroprotective effects to the hippocampus, and side effects of the treatment may include nausea and vomiting. 

How CBD is Becoming a Mainstream Treatment Option

But the benefits of CBD may not be accessible to everyone. Despite the ubiquity of CBD and hemp shops across the U.S., many patients still lack access to the versatile cannabinoid. Although hemp is federally legal, many state legislators still have difficulty differentiating between its components, continuing to lump THC and CBD into the same category of dangerous substances, nearly 100 years after the implementation of the Marihuana Tax Act.

On a public health scale, the legal status of CBD is problematic. Ensuring high-quality care across diverse populations hinges on the concept of ranges — ranges of populations, conditions, choices, where both providers and patients can work together with a variety of options to create personalized treatment plans. Especially for those patients who have tried other methods without success, access to CBD may be paramount to long-term healing.

We still have a long way to go before the entire nation has access to alternative treatments like CBD and its potential benefits. Despite legal roadblocks, plenty of research on cannabidiol is being conducted, including the creation of enzymatic networks in yeast strains. As such, CBD promises to be an exciting component of the medical landscape well into the future.

(http://www.pharmamicroresources.com/)

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