PhamExtracta INSIGHTS, News and Expertise

A new clinical study further supports the efficacy of Gabapral®, a precision psychobiotic containing Bifidobacterium adolescentis PRL2019, in children suffering from Irritable Bowel Syndrome (IBS) with recurrent abdominal pain. Conducted as a multicenter, randomized, double-blind, placebo-controlled trial, the study demonstrated a significant reduction in both the frequency and intensity of abdominal pain. Additionally, children receiving Gabapral® showed improved stool consistency and overall symptom remission compared to the placebo group. These findings reinforce the role of B. adolescentis PRL2019 as a GABA-producing probiotic with potential therapeutic applications in pediatric IBS.

Sophy® is a clinically validated supplement formulated with Berberine Phytosome®, designed to support women with Polycystic Ovary Syndrome (PCOS). A recent pilot, non-interaction, supplement registry study evaluated its safety profile when used alongside various chronic pharmacological therapies, including antiplatelet agents, anticoagulants, antihypertensives, diabetes management drugs, and thyroid medications.
The results confirmed no significant interactions between Sophy® and these medications. Moreover, no adverse effects or tolerability issues were reported, and patient compliance exceeded 96%, reinforcing its safety as a complementary treatment.

Hyperuricemia, characterized by elevated serum uric acid levels, is increasingly recognized as a risk factor for metabolic, renal, and cardiovascular diseases beyond its well-known link to gout. While dietary modifications offer limited reductions in uric acid levels, innovative approaches are needed for effective management.
A recent study demonstrated that Quevir®, based on Quercetin Phytosome®, may offer a safe, well-tolerated, and scientifically supported solution for hyperuricemia.

Kramegin® Vaginal Douche (MD) is a scientifically formulated medical device designed to provide safe and effective intimate hygiene. It combines boric acid, which eliminates harmful microorganisms, with the protective properties of Krameria triandra extract, offering additional benefits. Unlike conventional douches that may disrupt vaginal microbiota, Kramegin® is specifically designed to support vaginal health in cases of infections, post-menstrual cleansing, post-surgical hygiene, and postpartum recovery.

Zantogin® Gel offers a science-backed, natural solution for women navigating the challenges of menopause or vaginal dryness. By harnessing the power of Zanthalene® and other synergistic ingredients, it delivers fast, effective relief and long-term benefits. Whether managing post-menopausal symptoms or seeking enhanced comfort in daily intimate care, Zantogin® Gel empowers women to reclaim their well-being with confidence.

A recent study underscores the effectiveness of Meloff®, revealing significant improvements in overall sleep quality and a pronounced increase in deep sleep duration. With this new research, Meloff® reinforces its role as a groundbreaking, non-addictive alternative to traditional remedies for mild insomnia.
This innovative supplement harnesses the sleep-enhancing benefits of lemon balm and utilizes Phytosome® technology to ensure optimal absorption of its active compounds.

Antibiotics, though essential in combating bacterial infections, often disrupt gut microbiota, leaving patients vulnerable to gastrointestinal complications.
The introduction of Brevicillin®—a probiotic based on Bifidobacterium breve PRL2020 with intrinsic resistance to amoxicillin and amoxicillin-clavulanate—marks a pivotal step in safeguarding gut health during antibiotic therapy.

Sophy® with Berberine Phytosome® offers a superior solution for managing Polycystic Ovary Syndrome (PCOS) by enhancing berberine’s bioavailability and effectively addressing insulin sensitivity, hormonal balance, and lipid profiles.
A recent study shows that berberine outperforms metformin and myo-inositol in improving key PCOS parameters, making Sophy® a potent natural alternative.

As a safe, non-addictive alternative to conventional insomnia treatments, Meloff^® stands out as a compelling option. This new food supplement utilizes the benefits of Melissa officinalis (lemon balm) leveraging the Phytosome^® technology to boost absorption and effectiveness. With its remarkable ability to enhance sleep quality, Meloff^® is a natural choice for individuals seeking restful sleep and improved quality of life.

Bactorinol^®, available as nasal drops since 2021 in Italy, has gained international interest and is now available in a convenient spray format.
Formulated with Winterized Lentisk Oil (WLO) from Pistacia lentiscus berries, it has been clinically proven to reduce biofilm formation and alleviate Chronic RhinoSinusitis (CRS) symptoms, with recent studies confirming significant improvements in both biofilm presence and overall symptom relief.

Berberol^®, a nutraceutical combining Berberis aristata and Silybum marianum, has shown promise in improving glycemic control and reducing insulin resistance.
A recent meta-analysis highlights its effectiveness in lowering blood glucose and HbA1c levels, thanks to the synergistic action between berberine and silymarin. Berberol^® is effective both as a standalone and adjunctive therapy, offering a valuable option for managing glycemic issues.

Bactorinol^® is a medical device available as nasal drops, formulated with Winterized Lentisk Oil (WLO) derived from Pistacia Lentiscus berries. This unique ingredient has been shown to reduce biofilm formation and alleviate Chronic RhinoSinusitis (CRS) symptoms.
Recent research further supports its efficacy, demonstrating significant improvements in CRS outcomes, including a substantial reduction in biofilm presence and related symptoms.

Crispact^®, a precision probiotic containing Lactobacillus crispatus M247, has been selected as a finalist for the CPHI Pharma Awards for the third time, following its recent success at the NutraIngredients Awards. This continued recognition highlights the strength of the research behind Crispact^®, including a recent pivotal study on its role in assisted reproductive technology (ART), which has significantly enhanced the understanding of its applications in fertility treatments. Despite its wide-ranging evidence in other fields, this ART study marks a crucial development for the product.

There is growing interest in natural supplement for PCOS like Inositols and Berberine.
Inositols help improve insulin sensitivity, but may not be effective for all.
Berberine, particularly in its enhanced form as Berberine Phytosome^®, offers broader benefits by improving insulin sensitivity, reducing androgen levels, and enhancing ovulation. This makes Sophy^®, a unique clinically studied supplement featuring Berberine Phytosome^®, a promising option for managing various aspects of PCOS.

Crispact^®, containing Lactobacillus crispatus M247, is a precision probiotic that combats bacterial vaginosis (BV) by reducing the virulence of Gardnerella vaginalis. It achieves this by decreasing the expression of key virulence factors, vaginolysin and sialidase, and blocking pathogen adherence to vaginal epithelial cells.
Crispact^® is highly effective in promoting vaginal health and preventing recurrent BV, earning the 2024 NutraIngredients Award for Best Finished Product of the Year for Microbiome Modulation.

Two of our products, Crispact^® and Sophy^®, won at NutraIngredients Awards Europe 2024, showcasing their excellence in women’s health solutions.

Crispact^® is recognized for its ability to restore the vaginal microbiome and support HPV clearance, while Sophy^® effectively addresses PCOS symptoms with its potent Berberine Phytosome^®.

Discover PharmExtracta’s groundbreaking achievements! Two of our products, Crispact^® and Sophy^®, are finalists at NutraIngredients Awards Europe 2024.
Join us at Vitafoods, stand Q90, to witness how Crispact^® and Sophy^® revolutionize women’s well-being. Don’t miss the chance to explore our innovative solutions: mark your calendars and visit our booth to learn more.

Chasteberry extract, recognized by the EMA since 2010, is a potent ally against menstrual disorders and PMS, targeting prolactin and progesterone levels.
A recent study examined MonoSelect^® Agnus in managing PMS, showcasing significant symptom reduction, especially with continuous usage, offering a promising treatment avenue.

To address Genitourinary Syndrome of Menopause (GSM), PharmExtracta developed Zantogin^® vaginal gel, a patented medical device containing highly purified plant extracts and hyaluronic acid to provide healing, re-epithelizing, and moisturizing effects.
A recent study conducted at Sapienza University of Rome demonstrates the positive impact of Zantogin^® Gel on post-menopausal women suffering from GSM. Study results show not only a significant improvement in GSM symptoms but also a remarkable decrease in dyspareunia and improvements in the Vaginal Health Index, Female Sexual Distress Scale, and Regular Sexual Activity.

Non-Alcoholic Fatty Liver Disease (NAFLD) is a prevalent and potentially serious condition affecting millions worldwide. Often diagnosed alongside lifestyle recommendations, it is crucial to explore alternative interventions to improve liver health and prevent the progression of the disease.
Hepa G^®, with its unique formulation and patent protection, emerges as a promising solution to enhance liver health, offering new hope and possibilities for individuals facing the challenges of NAFLD.

Antibiotics remain a fundamental tool crucial for saving lives. However, their overuse or misuse can adversely affect the gut microbiota, leading to both short-term and long-term consequences.
Brevicillin^® is a novel probiotic that features the strain Bifidobacterium breve PRL2020, specifically identified to mitigate the detrimental effects of therapies involving amoxicillin and amoxicillin/clavulanic acid. The unique intrinsic resistance to these antibiotics of Bifidobacterium breve PRL2020 ensures a completely safe profile.

Over 40% of patients suffering from Gastroesophageal Reflux Disease still grapple with symptoms despite relying on proton pump inhibitors (PPIs). A dedicated review explores advanced therapies to support them, unveiling Mirgeal^® gel as a revolutionary adjunctive treatment.
With unique ingredients like licorice extract and Mirtoselect^®, Mirgeal^® gel outperforms traditional options, providing lasting relief and transforming GERD care.

PCOS poses challenges affecting various aspects of women’s lives, often hindered by limited treatment options and side effects from conventional therapies.
Sophy^® addresses these issues by harnessing Berberine’s potential, with the innovative Berberine Phytosome^® that enhances absorption, making Berberine 10 TIMES MORE bioavailable.
A recent clinical trial demonstrated remarkable results in just 3 months, including an 80% decrease in menstrual disorders, a 70% decrease in ovarian polycystosis, and a 55% decrease in acne.

The rise in infertility rates has prompted the growth of ART procedures. A recent study assesses the potential role of Crispact^® with Lactobacillus crispatus M247 in enhancing the success of ART for 160 infertile women undergoing various procedures.
Results in treated women show a 36% increase in positive pregnancy tests, 88% in D5 embryo transfers, and 67% more live births compared to the control group. These promising outcomes undoubtedly open up dialogue on Crispact^®‘s role in fertility treatments.

According to science, the benefits of Nigella sativa include anti-inflammatory, antioxidant, immune support, and more. However, when choosing a supplement based on this botanical, Thymoquinone concentration is crucial.
Nisatol^® maximizes the potential of Nigella Sativa with a 10% Thymoquinone content. Furthermore, its unique formulation ensures optimal absorption, featuring enteric coating and Vitamin E to guard against oxidation.

Research shows that berberine with silymarin has better absorption than berberine alone. A 2018 meta-analysis focused specifically on studies examining this combination, and after evaluating 26 studies, only 5 studies on Berberol^® were found to be eligible.
Berberol^® is the most studied product containing a fixed combination of berberine and silymarin, which enables a much better absorption of berberine and unlocks its impressive potential to improve metabolic parameters.

Crispact^®: A Precision Probiotic for Women’s Health, CPHI Pharma Awards 2023 Finalist.
It contains Lactobacillus crispatus M247 that excels in vaginal health with clinical evidence confirming its action in support of HPV clearance and ongoing studies delving into other gynecological issues.

A groundbreaking choice for gynecological health.

Fibradis^® is a revolutionary supplement addressing gut health and is a finalist at the NutraIngredients-Asia Awards, highlighting its commitment to innovation. It effectively targets gut dysbiosis symptoms and has shown remarkable results in clinical trials for IBS patients.
Its unique bipartite sachet makes it convenient for children, while its patented blend of fibers nourishes specific gut bacteria, restoring ideal balance. Fibradis^® is not just a supplement: it’s a precision prebiotic transforming gut health, with plans to reach new markets.

PCOS is a common endocrine disorder in women, which involves hormonal imbalances and metabolic issues and takes a toll on both physical and emotional well-being. Unfortunately, current treatments often have drawbacks.
A recent Italian study investigates the potential of Berberine Phytosome^® to help PCOS-diagnosed women relieve their symptoms. Results are noteworthy, showing reduction in insulin resistance, improved hormonal profiles, reduced hyperandrogenism, and acne amelioration.

GABA is an inhibitory neurotransmitter in the brain that helps regulate anxiety and stress responses. It is believed that increasing GABA levels in the brain may have a calming effect on the nervous system and potentially reduce anxiety and stress.
GABApral^® is a new psychobiotic containing Bifidobacterium adolescentis PRL2019, a very unique strain that has shown a high capability of producing GABA both in vitro and in vivo and can therefore offer a help to individuals dealing with chronic anxiety, stress or associated problems.

Cranberry products have been used for several decades to prevent urinary tract infections (UTIs). Recently a Cochrane review has pointed out the mechanism underlying cranberry activity: the compounds known as Proanthocyanidins (PACs) interfere with the adhesion of bacteria, making it more difficult for them to cause an infection.
MonoSelect^® Macrocarpon is a clinically tested supplement that helps prevent UTis thanks to its important content in PACs and the enteric coating that avoids the degradation by stomach acids.

HPV infection can be worrying since some types of HPV are associated with the development of cervical cancer, so a rapid viral clearance is crucial to serenity.
Lactobacillus crispatus M247 is the only probiotic that has been studied for its capability of promoting HPV clearance. Moreover, it shows a very high colonization profile of the vaginal environment where it creates the ideal conditions to prevent vaginal infections from several pathogens.

Statins are important drugs because of their effectiveness in lowering cholesterol. However, some people may experience adverse effects during the treatment, particularly when taking high dosages.
Berberol^® can help in controlling high LDL cholesterol and may be recommended as complementary approach to statin therapy, to reduce the dosage by half while maintaining an optimal lipid level.

Do you know that taking Amoxicillin/Clavulanic acid disrupts the gut microbiota and, particularly, causes a dramatic drop in Bifidobacteria?
This prompted us to search for a bifidobacterial strain that is able to resist to AMC and that could be developed in a probiotic supplement to be taken in conjunction with this antibiotic therapy.
Here comes the birth story Brevicillin^®: the only probiotic containing the special strain Bifidobacterium breve PRL2020 with intrinsic resistance to AMC.

Anxiety and Insomnia can significantly impair day-to-day functioning. To treat these conditions doctors may prescribe benzodiazepines, which are potent medications but unfortunately, have quite a few drawbacks.
Neurofast^® has been shown to perform really well on anxiety and insomnia, similarly to benzodiazepines, but it is natural and side-effect free. It comes in three-layer tablets to create a more structured and effective combination of actions.

Chasteberry extract has been studied for its activity against mild to moderate symptoms of Premenstrual syndrome.
MonoSelect^® Agnus is exquisitely formulated to fully exploit the potential of Chasteberry extract against PMS. It contains a high-quality extract and comes in fast-release tablets for a rapid absorption.

Introducing Dispepril^®: new and effective natural prokinetic formula that combines 300 mg of ginger root extract with 150 mg of bifractionated extract of perilla leaves (Perilla frutescens) showing a marked anti-dyspeptic activity both in gastric and intestinal sites.

The acute phase of hemorrhoids can be really debilitating, therefore affected patients need decisive therapies to manage this condition and relieving symptoms.
Emospid® contains highly standardized plant extracts boosted by advanced pharmaceutical technologies to provide a rapid relief. A clinical study confirms its effectiveness in the management of acute hemorrhoidal crises.

Berberol® is the first food supplement containing berberine that overcame the issue of the very poor bioavailability of this botanical ingredient thanks to its patented formulation featuring Silymarin.
The effectiveness of this supplement in blood sugar and blood fat control has been confirmed by several studies according to which Berberol® could be a treatment option for different kinds of patients.

Fibradis® is the only precision PREbiotic supplement containing a blend of fibers formulated to feed bacteria genus-specifically to promote the proliferation and colonization of bifidobacteria and lactobacilli in gut physiological proportions.
A study confirms the effectiveness of Fibradis® in reducing IBS symptoms.

Lactobacillus crispatus has become famous for the protective role it plays against vaginal infections and other gynaecological problems.
Lactobacillus crispatus M247, taken orally, is able to efficiently colonize the vaginal environment and exert its protective activities. Moreover, it can be used as add-on to metronidazole and boric acid.

Introducing Mirgeal® gel, innovative food supplement that rapidly relieves symptoms related to acid reflux performing better than alginate.
It features two botanical extracts able to protect against ulcers and re-epithelize gastric and esophageal mucosa with long-term benefits.

Introducing Bactorinol® nasal drops containing Winterized Lentisk Oil with antibacterial activity, able to disrupt bacterial biofilms to eradicate biofilm-related infections of the upper respiratory tract.
To be used alone or as add-on therapy to antibiotic therapies.