Atozin dosage – Atozin Fandel http://atozinfandel.com/ Wed, 23 Nov 2022 04:12:45 +0000 en-US hourly 1 https://wordpress.org/?v=5.9.3 https://atozinfandel.com/wp-content/uploads/2022/02/icon-2022-02-01T191236.650-150x150.jpg Atozin dosage – Atozin Fandel http://atozinfandel.com/ 32 32 Some adult painkillers can be carefully measured for children’s dosage, doctor says https://atozinfandel.com/some-adult-painkillers-can-be-carefully-measured-for-childrens-dosage-doctor-says/ Tue, 22 Nov 2022 16:53:24 +0000 https://atozinfandel.com/some-adult-painkillers-can-be-carefully-measured-for-childrens-dosage-doctor-says/ For desperate parents looking for painkillers for children amid nationwide shortages, they have the option of using a pill cutter on adult-sized pills to create smaller doses, doctor says family based in Toronto. But the process must be done very carefully using an appropriate tool and cannot be done by hand, said Dr. Marla Shapiro, […]]]>

For desperate parents looking for painkillers for children amid nationwide shortages, they have the option of using a pill cutter on adult-sized pills to create smaller doses, doctor says family based in Toronto.

But the process must be done very carefully using an appropriate tool and cannot be done by hand, said Dr. Marla Shapiro, CTV News medical specialist and associate professor in the Department of Family and Community Medicine at the University of Toronto. .

Although one million bottles of children’s medicines are being imported into Canada this week, many parents don’t have time to wait for these to show up on drugstore shelves and need remedies now for children. who are battling fever, Shapiro told CTV News Channel on Tuesday.

“It’s been going on for months now, with no immediate response in sight, we hear there will be a million boxes on the shelves within a week, but it’s still happening,” she said.

The federal government announced Thursday that it had tapped into foreign supply chains to bring one million bottles of painkillers to Canada. Supplies, including liquid ibuprofen and liquid acetaminophen, will be given to hospitals, community pharmacies and retailers.

Parents are reminded that children who are not in respiratory distress should not be admitted to the emergency room due to an influx of patients across the country. The strain on hospitals is due to what some experts call, a “multi-demic” of respiratory syncytial virus (RSV), influenza and COVID-19.

Children’s hospitals across the country are stretched as many operate at 100% or more occupancy with wait times sometimes exceeding 24 hours. Some elective surgeries had been delayed to ease the pressure.

“If you can’t control your fever, parents feel really desperate and anxious,” Shapiro said.

In the absence of children’s medications to lower fevers, Shapiro says parents can carefully convert adult doses to younger children.

She says children under 12 pounds are the hardest to give medicine because there is no adult conversion. In these cases, she advises parents to speak to pharmacists.

“We do these conversions for infants, and then in older children we can actually take adult preparations of either acetaminophen or ibuprofen and do proper weight control to see how to convert those drugs,” Shapiro said.

She stressed the importance of doing the conversions accurately and with the proper tools to avoid overdoses.

“You really need to get a proper pill cutter, don’t try to do it by hand because it will be inaccurate,” Shapiro said.

For children between 50 and 70 pounds, she said parents can give an adult dose to curb the fever. Shapiro said there are dose-by-weight differences with acetaminophen and ibuprofen.

“If you’re looking at ibuprofen…six to eight hours (in between), if you’re looking at acetaminophen, you’re looking at four to six hours in terms of dosage, but there’s a maximum dose per day that needs to be adhered to,” she says. .

Experts say more children (and adults) are getting sick this year because their immune systems haven’t been exposed in the past two years. This coupled with three viruses in circulation, parents want to understand how to stimulate the immune response.

“It’s about exposure and building your immunity,” Shapiro said. “With the exception of vitamin D, unless there’s a specific reason your child has malabsorption or something, there’s really no magic formula for boosting the immune system. here.”

Shapiro said most vitamins can be taken in through a healthy diet of fruits and vegetables and to ensure children sleep and exercise, to boost the immune system.

To avoid getting sick, she encourages everyone to continue wearing masks, wash their hands frequently and socially distance.

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Edible sensor provides real-time antiretroviral dosing data https://atozinfandel.com/edible-sensor-provides-real-time-antiretroviral-dosing-data/ Thu, 17 Nov 2022 16:04:53 +0000 https://atozinfandel.com/edible-sensor-provides-real-time-antiretroviral-dosing-data/ HIV-positive patients received real-time antiretroviral dosing data from an innovative edible sensor as part of a clinical trial. An innovative ingestible sensor technology tested in an interventional clinical trial has provided HIV-positive patients with real-time antiretroviral dosing data, enabling them to better control their infection. The medication regimen of 130 HIV patients was monitored by […]]]>

HIV-positive patients received real-time antiretroviral dosing data from an innovative edible sensor as part of a clinical trial.

An innovative ingestible sensor technology tested in an interventional clinical trial has provided HIV-positive patients with real-time antiretroviral dosing data, enabling them to better control their infection.

The medication regimen of 130 HIV patients was monitored by the Proteus Digital Health Feedback (PDHF) information technology system, which allowed patients to know in real time when a medication dose had been taken. The data showed that participants were more adherent to antiretrovirals (ARVs), which allowed them to experience lower viral loads.

The study is one of the first to use an FDA-cleared ingestible sensor system for ARV therapy in HIV-infected adults. The results are an important step in measuring and monitoring medication adherence in HIV patients and in developing real-time interventions to improve patient adherence.

PDHF uses a tiny edible sensor that is over-encapsulated with drugs. When ingested, it is detected by a patch with an integrated monitor and sensor worn by patients. The monitor transmits a Bluetooth signal to a mobile device, which sends an encrypted message to a central server.

Clinical Trial Data for the Ingestible Sensor

Participants were recruited from HIV clinics in the United States, randomized 1:1 to an IS or usual care (UC) group (information system).

The primary outcome of the intervention program was adherence to antiretroviral therapy (ART). Secondary outcomes included participant system satisfaction/acceptability and plasma HIV RNA. According to the researchers, higher levels of adherence to ARVs are associated with better plasma control of HIV RNA. The overall satisfaction rate for the system was over 90%. A total of 112 (SI=54, (UC=58) participants who completed baseline with at least one follow-up data collection were included in the analyses.

“When patients first enrolled in our study, they had issues with consistent adherence to their medications,” said Dr. Eric Daar, study co-principal investigator and Division Chief of Medicine. of HIV at Harbor-UCLA Medical Center and Professor of Medicine at the David Geffen School of Medicine at UCLA.

Daar added that participants often indicated that the system provided the additional feedback and support they needed to successfully control their HIV infection.

“After more than two decades of technology improvements, ingestible sensor technology is, to date, the most advanced and accurate computational method for measuring and monitoring adhesion behavior with wireless and online processes. real-time via a mobile device,” said Dr. Honghu Liu, co-principal investigator of the study and chair of the section of population and public health at UCLA School of Dentistry.

Investigators from UCLA, Nebraska Medical Center, Yale University and Harvard University were part of the research team that assessed the accuracy of the systems and assessed the effectiveness of monitoring and optimization of medication adherence.

A $4 million grant from the National Institute of Mental Health (NIMH) supported the research.

The findings were published in The Lancet Ebiomedicine.

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Appropriate rituximab dosing for NMOSD associated with lower risk of adverse events https://atozinfandel.com/appropriate-rituximab-dosing-for-nmosd-associated-with-lower-risk-of-adverse-events/ Wed, 16 Nov 2022 22:11:19 +0000 https://atozinfandel.com/appropriate-rituximab-dosing-for-nmosd-associated-with-lower-risk-of-adverse-events/ In a systematic review and meta-analysis, rituximab (Rituxan; Genentech), a drug to prevent relapses in neuromyelitis optica spectrum disease (NMOSD), was shown to be a safe treatment, particularly at a dose of 100 mg per week for 3 consecutive weeks. This meta-analysis provided insight into the choice of immunosuppressive therapy dosage for patients with NMOSD […]]]>

In a systematic review and meta-analysis, rituximab (Rituxan; Genentech), a drug to prevent relapses in neuromyelitis optica spectrum disease (NMOSD), was shown to be a safe treatment, particularly at a dose of 100 mg per week for 3 consecutive weeks. This meta-analysis provided insight into the choice of immunosuppressive therapy dosage for patients with NMOSD to help clinicians understand rituximab to make better clinical application decisions.1

Rituximab showed a significant reduction in annual recurrence rate (ARR) (mean difference [MD]= -1.79, 95% CI: -3.18 to -0.39, P = 0.01) and Expanded Disability Status Scale (EDSS) (MD = -1.35, 95% CI: -1.5 to -1.19, P <.00001) at a rate of 100 mg intravenous infusion per week for 3 consecutive weeks, while increasing the number of patients without relapse (rate ratio [RR].24.61; 95% CI, 5.11-118.55; P <.0001) and being relatively safe and without serious adverse events (SAEs).

Co-lead author Kenhui Wei, Department of Neurology, The First Affiliated Hospital of Soochow University, Suzhou, China, and colleagues wrote: “From the perspective of ARR, patients treated with 100 mg/wk for 3 weeks of rituximab had significantly lower levels of relapse. There was also a significant difference in the number of relapse-free patients before and after rituximab treatment. For EDSS scores, 100 mg/s for 3 weeks was effective in preventing or delaying disability progression. »1

Reviewers searched PubMed, Embase, the Cochrane Library and Clinicaltrials.gov for relevant studies up to March 2022 on the evaluation of rituximab for NMOSD, with data analyzed using Review Manager 5.3 and Stata 14 software. Random-effects models were used for the analysis of means and standard deviations as well as relative risk.

A total of 576 patients in 17 studies were analyzed for the review. The change in ARR, EDSS and number of relapse-free patients between pre-treatment and post-treatment of rituximab was the primary efficacy endpoint. Regarding safety, the reviewers summarized and compared adverse events (AEs) and serious AEs from the selected studies.

Wei et al noted that studies found that “1000 mg twice two weeks apart is effective in reducing ARR and EDSS, but AEs, SAEs, and high costs make it less likely to Low doses of rituximab at 100 mg/week for 3 weeks were significantly effective in reducing rates of ARR and disability, with less financial burden on patients or the public health system, and risk fewer adverse events than other doses.”1

Other additional results showed that patients treated with rituximab 375 mg/m2 weekly for 4 weeks and 1000 mg given twice two weeks apart were associated with a significantly higher risk of SAEs and AEs . Overall, 3 deaths occurred in this treated group, with aspiration pneumonia, disease complication, and myelitis that involved the medulla oblongata as 3 causes.

Limitations of this analysis included some biases found in most cohort studies that accounted for the low prevalence, high recurrence rate, and high disability, even fatality, of NMOSD. Additionally, no statistical analysis was performed on prior immunosuppressive therapy and therefore this review was not recorded prior to data collection. The role of maintenance treatment was not considered even though a meta-regression analysis showed that the amount of rituximab doses did not affect ARR and EDSS scores in patients with NMOSD.2

“Further large-sample, long-term surveillance RCT studies of rituximab are expected in the future, with more efforts to determine the optimal dose and duration of rituximab, assess patient-level risk factors and identify the population most at risk of IE. . We look forward to further studies related to rituximab so that it may have a promising future in the therapeutic strategy of NMOSD,” noted Wei et al.1

REFERENCES
1. Wei K, Nie Q, Zhu Y, Lu H, Xue Q, Chen G. Different doses of rituximab for the treatment of neuromyelitis optica spectrum disorder: systematic review and meta-analysis. Mult Scler Relat Disord. 2022;68:104127. doi:10.1016/j.msard.2022.104127
2. Damato V, Evoli A, Iorio R. Efficacy and safety of rituximab treatment in neuromyelitis optica spectrum disorders: systematic review and meta-analysis. JAMA Neurol. 2016;73(11):1342-1348. doi:10.1001/jamaneurol.2016.1637
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Feedback on challenges and innovations https://atozinfandel.com/feedback-on-challenges-and-innovations/ Tue, 15 Nov 2022 13:01:59 +0000 https://atozinfandel.com/feedback-on-challenges-and-innovations/ A look back at 2022 innovation challenges and highlights for oral solid dosage forms, this podcast episode will review insights from industry experts on the factors driving the evolution of OSD forms as well as innovations in APIs, technology and methodology. Highlights include expert commentary from LGM Pharma, Hovione, Syntegon and Colorcon. Sponsors About the […]]]>

A look back at 2022 innovation challenges and highlights for oral solid dosage forms, this podcast episode will review insights from industry experts on the factors driving the evolution of OSD forms as well as innovations in APIs, technology and methodology. Highlights include expert commentary from LGM Pharma, Hovione, Syntegon and Colorcon.

Sponsors

About the speakers

Deepak Thassu, Vice President R&D and Regulatory Submissions, LGM Pharma, joined LGM in 2020 to lead the company’s integrated R&D and Regulatory Submissions teams for CDMO clients. He launched commercial products with several US and European patents and managed submissions for NDAs, ANDAs, BLAs and medical devices. Prior to joining Nexgen in 2015 to lead the R&D and Regulatory groups, Deepak was Managing Director at Actavis, Chief Scientific Officer and Vice President of Pharmaceutical Development at PharmaNova, Chief Scientific Officer and Senior Vice President of Pharmaceutical Development at Holopack International, and Associate Director of global pharmaceutical development and technology at UCB Pharma. He received his Masters in Pharmacy from the University of Saugor and his Ph.D. and postgraduate training from the University of Cincinnati in Pharmaceutical Sciences. He earned MBAs from Cornell University, in General Business Administration and Finance, and Queen’s University.

Marco Gil, senior vice president of sales and marketing, Hovione, graduated from the chemical engineering department of the Technical University of Lisbon, where he also obtained a doctorate in chemistry in 2006. In 2007, he joined the R&D department of Hovione as a particle scientist. design disciplines. The focus of his work was the application of particle engineering technologies to improve the bioavailability of poorly water-soluble drugs. In May 2011, he was appointed Director of R&D Process Chemistry and was responsible for a group of scientists dedicated to the development and scale-up of chemical processes for the production of active ingredients. He held several management responsibilities, including General Manager of Hovione’s US site operations and trade-related functions. He is the author of more than 15 scientific articles in peer-reviewed journals and book chapters, co-author of two patents and invited speaker at more than 10 international conferences.


Alex Trombley
, Head of Business Development for the Huttlin Wallet Line at Syntegon. He spent five years at Eli Lilly and Co. working on formulation and process development work for oral solid dosage forms before joining Syntegon in 2021. Trombley has experience developing early-stage formulations , process identification, scale-up and technology transfer and has worked extensively with continuous manufacturing, high shear granulation, fluidized bed granulation, compression and coating. At Syntegon, he focuses on technical support, customer trials and market development for Huttlin products in North America. He studied chemical engineering with a minor in computer science at the University of Michigan.

Gary’s Pond is the Global Head of Authentication for Colorcon and is responsible for leading the overall strategy, business planning and operational execution of Colorcon’s in-dose authentication business. Pond has over 25 years of experience in product management, marketing, operations, and digital transformation, and is a recognized leader in on-dose authentication. Prior to Colorcon, Pond held senior marketing and operational positions at Sanofi, Merck & Co, Abraxis Bioscience and IQVIA.

Ali Rajabi-Siahboomi is vice president and chief innovation officer at Colorcon, based at global headquarters in the United States. Rajabi-Siahboomi held various academic positions at JM Universities of Nottingham and Liverpool in the UK before joining Colorcon as Technical Director, responsible for Europe, Middle East and Africa in 2000. His Major research interests are pharmacy in solid dosage form, pharmaceutical technology with emphasis on oral drug delivery systems, solubility enhancement to improve bioavailability and consistency of drugs and formulations of bioequivalence. He has published over 300 articles, book chapters, abstracts and patents and earned his B.Pharm. and Doctor of Pharmacy from the University of Nottingham (UK).

About the Drug Solutions Podcast

Pharmaceutical technology features the Drug Solutions podcast, where editors will chat with industry experts from across the pharmaceutical and biopharmaceutical supply chain. Join us as experts share their insights on your biggest questions, from technologies to strategies to regulations related to drug development and manufacturing.

Listen to this podcast on SoundCloud, Spotify, Google Podcasts or Apple Podcasts.

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MegaPro Biomedical MPB-1734 Receives Composition Patent for New Dosage Form of Cancer Drug That Enhances Combination Immunotherapy https://atozinfandel.com/megapro-biomedical-mpb-1734-receives-composition-patent-for-new-dosage-form-of-cancer-drug-that-enhances-combination-immunotherapy/ Tue, 15 Nov 2022 02:41:00 +0000 https://atozinfandel.com/megapro-biomedical-mpb-1734-receives-composition-patent-for-new-dosage-form-of-cancer-drug-that-enhances-combination-immunotherapy/ EQS Newswire / 11/15/2022 / 10:41 GMT+8 MegaPro Biomedical (6827) Press release on MegaPro Biomedical receiving a composition patent for MPB-1734, a new 505(b)(2) cancer drug formulation. Release date: November 152022 MegaPro Biomedical MPB-1734 Receives Composition Patent for New Dosage Form of Cancer Drug That Enhances Combination Immunotherapy MegaPro Biomedical Co., Ltd. (hereinafter referred to […]]]>

EQS Newswire / 11/15/2022 / 10:41 GMT+8

MegaPro Biomedical (6827) Press release on MegaPro Biomedical receiving a composition patent for MPB-1734, a new 505(b)(2) cancer drug formulation.

Release date: November 152022

MegaPro Biomedical MPB-1734 Receives Composition Patent for New Dosage Form of Cancer Drug That Enhances Combination Immunotherapy

MegaPro Biomedical Co., Ltd. (hereinafter referred to as “MegaPro”, Taiwan’s OTC stock code: 6827) announces that the product MPB-1734, a new dosage form of cancer drug under its nano-micelle technology platform, has officially obtained the Notice of Allowance for his US composition patent. Additionally, MPB-1734 has been approved by the FDA (US) and TFDA (Taiwan) for Phase 1/2a clinical trials, and two subjects have been enrolled so far.

Dr. Yuan-Hung Hsu, Executive Vice President of MegaPro Biomedical, says that based on the unique nano-micelle technology, poorly water-soluble hydrophobic drugs can be stably dispersed in water while increasing its solubility by more than 1000 times, which an intravenous injection medical product can be established. This advance significantly improves the shortcomings of the currently commercially available formulation, which requires the use of emulsifiers with hypersensitivity issues and requires pre-treatment with steroids prior to injection. On the other hand, due to the characteristics of nanosizing, the biodistribution of drugs in the body is changed, which greatly reduces the side effects of chemotherapy drugs. At the same time, due to its feature of being able to avoid P-Glycoprotein drug efflux pump, there is an opportunity for MPB-1734 to be used on patients who have developed chemo- resistance.

Additionally, MegaPro reports that in the animal model of head and neck cancer, it has been found that treatment with MPB-1734 can significantly increase immune cell infiltration into tumors (Ex: CD8+ T cells). The changes in the tumor microenvironment also reflect the synergistic benefit of the antitumor effect, as the tumor inhibition rate of the combined immuno-oncology agent MPB-1734 was significantly higher than that of the immuno-oncology agent monotherapy. and MPB-1734. There is a great potential opportunity for MPB-1734 to be combined with immunotherapy in the future. In addition to its own therapeutic effect, MPB-1734 can also change the tumor microenvironment from a cold tumor which was believed to be ineffective for immunotherapy to a warm tumor, achieving the best combined treatment effect.

MegaPro further states that MPB-1734 is currently in clinical trials for patients with advanced solid tumors. Going forward, the company will target ovarian cancer and head and neck cancer, which have a high recurrence rate. For those who cannot continue to receive additional treatment due to the severe side effects of neutropenia, MPB1734 may provide them with a new, usable drug. MegaPro plans to expedite the clinical study process by seeking designation of new forms of 505(b)(2) drugs and orphan drugs from the U.S. FDA, hoping to benefit patients by providing new opportunities for treatment.

About MegaPro Biomedical Co., Ltd. :

MegaPro Biomedical Co., Ltd. (stock code: 6827) was founded in 2014 and spun off from the Industrial Technology Research Institute. It is a new pharmaceutical technology company mainly engaged in the development of niche nano-medicines. MegaPro has two nanotechnology platforms – “Nanoparticles” and “Nanomicrocells”, developing nano iron oxide products. Currently, the fastest growing products are injectable iron supplements and liver cancer imaging agents for iron deficiency anemia. Currently, MegaPro has developed three major products, namely iron supplement MPB-1514 for iron deficiency anemia, contrast agent MPB-1523 for MRI diagnosis of hepatocellular carcinoma, and MPB-1734, a new dosage form of anti-cancer drug.

For more information about the company, please visit the official website: https://www.megaprobio.com/

Statement:

This document and accompanying related information contain a predictive description. Excluding factual occurrences, all statements regarding future business operations, possible events, and prospects (including, but not limited to, forecasts, goals, estimates, and business plans) of MegaPro Biomedical Co., Ltd. (hereinafter referred to as the Company) are forward-looking statements. The forward-looking statement could be affected by various factors and uncertainties, causing the actual situation to differ materially. These factors include, but are not limited to, price fluctuations, actual demands, changes in exchange rates, market share, market competition, laws, finances and regulations. Structural changes, international economic and financial market conditions, political risks, cost estimates, etc., and other risks and variables are beyond the Company’s control. These forward-looking statements are predictions and assessments based on current conditions, and the Company is not responsible for any future updates.

File: MegaPro Biomedical MPB-1734 Receives Composition Patent for Novel Cancer Drug Dosage Form That Improved Combination Immunotherapy

11/15/2022 Distribution of a marketing press release, transmitted by EQS News.
The issuer is solely responsible for the content of this announcement.

Media archive at www.todayir.com

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Steroid dose taken for pain relief is safe, but not indefinitely | Lifestyles https://atozinfandel.com/steroid-dose-taken-for-pain-relief-is-safe-but-not-indefinitely-lifestyles/ Thu, 10 Nov 2022 17:00:00 +0000 https://atozinfandel.com/steroid-dose-taken-for-pain-relief-is-safe-but-not-indefinitely-lifestyles/ DEAR DR. ROACH: I need your advice. I was diagnosed with metastatic lung cancer nearly two years ago. I had chemotherapy treatments (Keytruda, carboplatin and Alimta) for over a year. My most recent CT and CT scans of my lungs were all stable with no changes. My oncologist says I don’t need to come back […]]]>

DEAR DR. ROACH: I need your advice. I was diagnosed with metastatic lung cancer nearly two years ago. I had chemotherapy treatments (Keytruda, carboplatin and Alimta) for over a year. My most recent CT and CT scans of my lungs were all stable with no changes. My oncologist says I don’t need to come back for three months and have another CT scan in six months.

My problem is that I have developed pain in my shoulders, legs and chest, which could be from my chemo treatment. My internist prescribed me 2.5 mg of prednisone twice a day, which relieves my pain. What are the long term side effects of this prednisone dosage? What do you think of my situation as a whole? — Anon.

ANSWER: Drugs to treat cancer (chemotherapy is a general term for any type of drug, but has come to refer to drugs specifically for cancer, and sometimes excludes immunological treatments, such as the Keytruda you have been taking) often have many side effects. Of the medicines you have taken, Keytruda is the one most likely to cause bone pain. However, I would still be concerned, as lung cancer can spread to the bones, and your oncologist or internist should have considered an evaluation to see if there is any evidence of this.

Steroids like prednisone are generally effective against bone pain related to cancer and its treatment. The dose you take is relatively low. Steroids certainly have the potential for many side effects, but this dose is quite safe. However, I hope that you will not continue to take prednisone indefinitely. If the pain is due to chemotherapy, I would expect it to fade over time.

Metastatic lung cancer (meaning it has spread outside of the primary tumour) is not considered curable, but treatments improve both the duration and quality of life. The fact that your cancer is not growing on imaging tests is a very good sign.

DEAR DR. ROACH: My great-aunt Rose died of pneumonia at 18, long before I was born. My mom told me Rose went out in the cold with wet hair, so she got sick. And she said we didn’t have penicillin yet, so Rose died. Anyway, needless to say, my sister and I don’t go out with wet hair. Why did people think you could get sick if you went outside with wet hair, especially in cold weather? Is there a possible link between going out in the cold with wet hair and getting sick? Everything I read says no, but this myth had to start somewhere. —HC

ANSWER: Colds are caused by viruses, and pneumonia can be caused by bacteria or viruses. Wet hair does not affect whether you are exposed to a virus or not. There remains controversy over whether the cold increases your susceptibility to contracting an infection from viruses or bacteria. Most studies have suggested there is no significant increase in risk, but one study showed a 10% increase in colds in people who had cold feet. Medicine folklore often contains a bit of truth, sometimes a lot more.

It is clear that low levels of humidity, common in temperate zones in winter, increase the ability to transmit viruses, but if there is an increased risk of colds for people who are cold or wet, the risk seems being weak.

Dr Roach regrets that we cannot respond to individual letters, but will incorporate them into the column whenever possible. Readers can email questions to ToYourGoodHealth@med.cornell.edu or send mail to 628 Virginia Dr., Orlando, FL 32803.

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The dose of steroids taken for pain relief is safe, but not indefinitely https://atozinfandel.com/the-dose-of-steroids-taken-for-pain-relief-is-safe-but-not-indefinitely/ Thu, 10 Nov 2022 14:50:57 +0000 https://atozinfandel.com/the-dose-of-steroids-taken-for-pain-relief-is-safe-but-not-indefinitely/ Dear Dr. Roach: I need your opinion. I was diagnosed with metastatic lung cancer nearly two years ago. I had chemotherapy treatments (Keytruda, carboplatin and Alimta) for over a year. My most recent CT and CT scans of my lungs were all stable with no changes. My oncologist says I don’t need to come back […]]]>

Dear Dr. Roach: I need your opinion. I was diagnosed with metastatic lung cancer nearly two years ago. I had chemotherapy treatments (Keytruda, carboplatin and Alimta) for over a year. My most recent CT and CT scans of my lungs were all stable with no changes. My oncologist says I don’t need to come back for three months and have another CT scan in six months.

Also: Diabetic patient continues to receive palliative care without medication

My problem is that I have developed pain in my shoulders, legs and chest, which could be from my chemo treatment. My internist prescribed me 2.5 mg of prednisone twice a day, which relieves my pain. What are the long term side effects of this prednisone dosage? What do you think of my situation as a whole?

— Anon.

Dear Anon. : Drugs to treat cancer (chemotherapy is a general term for any type of drug, but has come to refer to drugs specifically for cancer, and sometimes excludes immunological treatments, such as the Keytruda you’ve been taking) many side effects. Of the medicines you have taken, Keytruda is the one most likely to cause bone pain. However, I would still be concerned, as lung cancer can spread to the bones, and your oncologist or internist should have considered an evaluation to see if there is any evidence of this.

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Natrol Maximizes Melatonin Dosage with MelatoninMax https://atozinfandel.com/natrol-maximizes-melatonin-dosage-with-melatoninmax/ Thu, 10 Nov 2022 12:00:00 +0000 https://atozinfandel.com/natrol-maximizes-melatonin-dosage-with-melatoninmax/ Natrol provides consumers with the maximum recommended amount of melatonin with MelatoninMax. Containing 10 mg of melatonin per gummy, MelatoninMax is drug-free, formulated with clean, non-GMO ingredients and free of artificial flavors, sweeteners, preservatives and synthetic colors, the company said. [Read more: Natrol prioritizes revitalizing sleep with latest melatonin blends] “Healthy, regular sleep is a key […]]]>

Natrol provides consumers with the maximum recommended amount of melatonin with MelatoninMax.

Containing 10 mg of melatonin per gummy, MelatoninMax is drug-free, formulated with clean, non-GMO ingredients and free of artificial flavors, sweeteners, preservatives and synthetic colors, the company said.

[Read more: Natrol prioritizes revitalizing sleep with latest melatonin blends]

“Healthy, regular sleep is a key part of our overall well-being and feeling like we can be there every day,” said Harel Shapira, director of product management and innovation at Natrol. “Consumers are increasingly looking for drug-free sleeping pills and want a reliable source for occasional insomnia that will give them confidence that they will get the sleep they need to feel present in all aspects of their lives. They just don’t want to risk anything that might not work.With MelatoninMax, consumers can rely on just one serving of gum to help them sleep well and wake up feeling rejuvenated, which promotes whole body health.

Available in a blueberry flavor, MelatoninMax by Natrol is available in 50 and 80 unit packs which can be found online and at Walgreens, CVS Pharmacy and Kroger stores nationwide.

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Global Oral Solid Dosage Contract Manufacturing Market – Sales, Revenue and Market Share Analysis 2022 to 2032 https://atozinfandel.com/global-oral-solid-dosage-contract-manufacturing-market-sales-revenue-and-market-share-analysis-2022-to-2032/ Thu, 10 Nov 2022 08:59:42 +0000 https://atozinfandel.com/global-oral-solid-dosage-contract-manufacturing-market-sales-revenue-and-market-share-analysis-2022-to-2032/ According to the latest industry analysis by Persistence Market Research, the global oral solid dosage contract manufacturing market recorded sales worth US$23.4 billion in 2021 and is expected to grow at a CAGR of 5.9% from 2022 to 2032. Contract research organizations are outsourced companies that support pharmaceutical and biotechnology companies in their clinical and […]]]>

According to the latest industry analysis by Persistence Market Research, the global oral solid dosage contract manufacturing market recorded sales worth US$23.4 billion in 2021 and is expected to grow at a CAGR of 5.9% from 2022 to 2032.

Contract research organizations are outsourced companies that support pharmaceutical and biotechnology companies in their clinical and preclinical studies on a contractual basis. Manufacturing costs are increasing day by day. As a result, large and small pharmaceutical and biotech companies are focusing their efforts on CDMOs to secure long-term contract manufacturing agreements. This will help companies to stick to fixed manufacturing rates and CDMOs to improve manufacturing quality.

Tablets and capsules are the basic types of solid dosage forms. Companies today are using new technologies to increase the bioavailability of dosage forms to increase patient compliance. Contract manufacturers of oral solid dosage forms introduce new products or upgrade older products. For example, many patients, especially pediatric patients, have difficulty swallowing tablets. Therefore, time-release beads can help optimize the release rate. Companies also make sublingual tablets for quick medication.

Get Free Sample Copy of this Report @ https://www.persistencemarketresearch.com/samples/25768

The increasing complexity of new drug molecules will drive the market growth as CROs and CDMOs provide manufacturing with expertise to help manage the complexity of new molecules. Over the next few years, the development and contract manufacturing industry will be boosted by increased investment in infrastructure development and plant expansion, as well as CDMO’s capabilities to provide fully integrated services.

Since the oral solid dosage contract manufacturing market is consolidated with few key players, it presents many lucrative opportunities for new entrants to gain a foothold in this industry. The increase in strategic collaborations can also prove to be a beneficial factor for market players to expand their footprint.

Company Profiles:

  • Recipharm AB
  • AbbVie
  • Patheon NV (ThermoFisher Scientific)
  • Catalent Inc.
  • NextPharma
  • Capsugel (Lonza Group SA)
  • Aurobindo Pharma Limited
  • Siegfried AG
  • Piramal pharmaceutical solutions
  • Corden Pharma
  • Kremoint Pharma Pvt Ltd.
  • HERMES PHARMA Ltd
  • Medipaams India Private Limited
  • Alpex Pharma
  • Abaris Healthcare Pvt Ltd
  • Ardena Holdings S.A.
  • Aphena Pharma Solutions
  • Actiza Pharmaceutical Private Limited
  • Sunwin Healthcare PVT. LTD
  • Saffron Medicare PVT. LTD
  • Kosher Pharmaceuticals
  • Dr. Reddy’s Laboratory
  • GlaxoSmithKline Plc
  • Boehringer Ingelheim BioXcellence
  • Aenova Holding

Methodology Request @ https://www.persistencemarketresearch.com/methodology/25768

Key insights from market research

  • The galenic form of tablets accounted for 34% market share in 2021.
  • Pharmaceutical product development held around half of the overall market share, by value, in 2021.
  • The immediate release mechanism has a market share of 53.7%.
  • The limited availability of resources and the increased focus on reducing R&D and operational costs are the main reasons why small and medium-sized pharmaceutical or biotechnology companies are opting for outsourcing. As such, these companies dominate the end-user segment and captured around 32% market share in 2021.
  • The North American contract manufacturing market for solid oral doses accounted for 25.2% of the global market share.

“Rising strategic collaborations between pharma giants and emerging players will drive the demand for contract manufacturing of oral solid doses over the coming years,” says an analyst from Persistence Market Research.

Market competition:

Leading oral solid dosage contract manufacturing vendors are investing in R&D activities to develop new technologies for the development of solid dosage formulations. Along with R&D investments, major players are also aiming for various expansions to create goodwill and successfully establish their presence in the global market.

  • In January 2022, Lonza, Forbion and BioGeneration Ventures extended their collaboration to include small molecule development and manufacturing services.

What does the report cover?

Persistence Market Research offers a unique perspective and actionable insights into the Oral Solid Dosage Contract Manufacturing Market in its latest study, presenting a historical demand assessment from 2017 to 2021 and projections for 2022 to 2032.

The research study is based on the dosage form (tablets {conventional release, modified release, chewable tablets, effervescent tablets}, capsules {hard gelatin capsules, soft gelatin} capsules/capsules; powders and granules; lozenges and lozenges; gums), mechanism (immediate release; delayed release; controlled release), application (pharmaceutical product development; manufacture of fillers and finishes; packaging/labelling; others) and end user (large pharmaceutical/biotech companies; small and medium pharmaceutical/biotechnology companies; emerging/virtual pharmaceutical companies; nutraceutical companies), in seven key regions of the world.

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Processa Pharmaceuticals: Next-Generation Capecitabine (NGC) Dosing Regimens Identified in Ongoing Phase 1B Trial with Potentially Better Safety and Efficacy Profiles Than Existing Chemotherapy – Form 8-K https://atozinfandel.com/processa-pharmaceuticals-next-generation-capecitabine-ngc-dosing-regimens-identified-in-ongoing-phase-1b-trial-with-potentially-better-safety-and-efficacy-profiles-than-existing-chemotherapy-form/ Fri, 04 Nov 2022 15:32:11 +0000 https://atozinfandel.com/processa-pharmaceuticals-next-generation-capecitabine-ngc-dosing-regimens-identified-in-ongoing-phase-1b-trial-with-potentially-better-safety-and-efficacy-profiles-than-existing-chemotherapy-form/ Next-generation capecitabine (NGC) regimens have been identified in the ongoing Phase 1B trial with potentially better safety and efficacy profiles than existing chemotherapy ● These NGC regimens are significantly more potent than FDA-approved capecitabine therapy, based on greater systemic and tumor exposure to 5-fluorouracil (5-FU), the major metabolite of capecitabine. ● These NGC regimens form […]]]>

Next-generation capecitabine (NGC) regimens have been identified in the ongoing Phase 1B trial with potentially better safety and efficacy profiles than existing chemotherapy

These NGC regimens are significantly more potent than FDA-approved capecitabine therapy, based on greater systemic and tumor exposure to 5-fluorouracil (5-FU), the major metabolite of capecitabine.

These NGC regimens form fewer metabolites that cause only dose-limiting side effects without tumor-killing properties.

Processa will meet with the FDA in 2023 to confirm that the Phase 2B trial design is consistent with the FDA’s Project Optimus Oncology initiative to identify optimal dosing regimens while moving away from the maximum tolerated dosing approach of the past .

In 2023, Processa plans to begin recruiting patients for the Phase 2B trial to identify treatment regimens that improve the efficacy-safety profile compared to the current treatment.

HANNOVER, MD – November 1, 2022 – Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), a diversified clinical-stage company developing products to improve survival and/or quality of life for patients with an unmet medical need, announces announcing positive results from its ongoing Phase 1B trial of next-generation capecitabine (NGC). The data collected allowed Processa to estimate the timing of irreversible dihydropyrimidine dehydrogenase (DPD) inhibition and the formation of new DPD after administration of PCS6422. NGC regimens (ie, a variety of PCS6422 regimens combined with a variety of capecitabine regimens) have also been identified as safe with different systemic and tumor exposure profiles to 5-FU. These results will allow Processa to evaluate several regimens with different tumor exposures to 5-FU in the Phase 2B trial with the aim of identifying NGC regimens that offer an improved efficacy and safety profile compared to the current treatment. .

During the first 24 to 72 hours after administration of PCS6422 in the Phase 1B trial, less than 10% of 5-FU was converted to metabolites that only cause side effects (i.e. catabolites), significantly less than the 80% reported for FDA-approved capecitabine. The potency of NGC (estimated from systemic exposure to 5-FU) was approximately 50 times greater than the potency of FDA-approved capecitabine. Additionally, the half-life of 5-FU after initial administration of PCS6422 and capecitabine was found to be significantly higher at 2-6 hours compared to the typical 5-FU half-life of approximately 45 minutes. after administration of capecitabine.

Because 5-FU exposure is dependent on both the PCS6422 regimen and the capecitabine regimen, Processa identified both NGC regimens that are safe as well as regimens that cause dose-limiting toxicities, as has was observed in one patient in the phase 1B trial who had progressive disease. stage 4 cancer. This patient had grade 4 neutropenia, was admitted to hospital and subsequently died.

Dr. David Young, President and CEO of Processa, said, “We have identified NGC treatment regimens that have significantly greater potency than existing therapy and no dose-limiting side effects, unlike capecitabine therapy. In addition, we understand the effect of different NGC dosing regimens on the timing of irreversible DPD inhibition and production of new DPD by a patient, allowing us to better define the relationship between various NGC dosing regimens, 5-FU exposure, and NGC safety.”

Dr Young added: “The next step will be to demonstrate in a Phase 2B trial that these NGC regimens also have better efficacy than the existing therapy and, therefore, provide a significant improvement in the benefit-risk profile compared to the existing therapy. We plan to use a Phase 2B trial to determine which regimens offer this improved efficacy and safety profile over the current treatment using the principles of the FDA’s Oncology Project Optimus initiative to guide us in the design of the regimen. ‘trial. In 2023, Processa plans to meet with the FDA to discuss the design of our Phase 2B trial and initiate the trial.

Next Generation Capecitabine

Next-generation capecitabine (NGC) is a combination of a PCS6422 regimen and a distinct capecitabine regimen. Capecitabine is a fluoropyrimidine, like 5-fluorouracil (5-FU), the main metabolite of capecitabine, which remains the cornerstone of treatment for many types of cancers in approximately two million patients per year. Capecitabine is an oral prodrug of 5-FU and approved as first-line treatment for metastatic colorectal and breast cancer. Adverse effects of capecitabine such as the development of hand-foot syndrome from 5-FU catabolites (eg, α-fluoro-β-alanine (F-Bal)) and neutropenia from 5-FU anabolites -FU (eg, phosphate metabolites) can have serious adverse effects on a patient’s daily activities, quality of life, and may require dose interruptions, adjustments, or discontinuation of therapy, all leading to suboptimal tumor therapy.

PCS6422 is an oral, potent, selective and irreversible inhibitor of dihydropyrimidine dehydrogenase (DPD), the enzyme that rapidly metabolizes 5-FU to catabolites that can cause dose-limiting side effects. The formation of 5-FU anabolites in cancer cells and normal cells is not dependent on DPD.

By combining the PCS6422 and capecitabine regimens, altering 5-FU metabolism and hence elimination leads to an increase in capecitabine potency, as determined by systemic exposure to 5-FU per mg capecitabine administered. . As a result, less capecitabine is needed to kill cancer cells and to treat each patient. To date, Processa has found that irreversible inhibition of DPD by PCS6422 can alter 5-FU clearance, making NGC significantly more potent (more than 50 times more potent) and potentially leading to higher levels anabolites that can kill cancer replication. and normal cells causing dose-limiting side effects such as neutropenia. When administering NGC to cancer patients, the balance between anabolites and catabolites changes depending on the dosage regimens of PCS6422 and capecitabine used, making the efficacy and safety profile of NGC different from that of approved capecitabine. by the FDA and requiring further evaluation of PCS6422 and capecitabine treatment regimens to determine optimal next-generation capecitabine treatment regimens for patients.

The projected market for NGC is $500 million to $1 billion in the United States for the treatment of colorectal cancer and over $1 billion in the United States for the treatment of the many cancers for which capecitabine is used. The potential global market for NGC for colorectal cancer exceeds $1 billion.

About Processa Pharmaceuticals, Inc.

Processa’s mission is to develop products with existing clinical evidence of efficacy for patients with unmet or underserved medical conditions who need treatment options that improve survival and/or quality of life. The Company uses its regulatory science approach criteria when selecting drugs for development in order to achieve high-value milestones effectively and efficiently. Active clinical pipeline programs include: PCS6422 (metastatic colorectal cancer, breast cancer), PCS12852 (gastroparesis, functional constipation) and PCS499 (ulcerative lipoid necrobiosis). Members of the Processa development team have participated in over 30 indication approvals in nearly every division of the FDA (including drug products targeted at orphan diseases) and over 100 FDA meetings throughout throughout their career. For more information, visit our website at www.processapharma.com.

Forward-looking statements

This press release contains forward-looking statements. Statements contained in this press release that are not purely historical are forward-looking statements that involve risks and uncertainties. Actual future performance and results may differ materially from those expressed in forward-looking statements. Please refer to Processa Pharmaceuticals’ filings with the SEC, in particular the most recent reports on Forms 10-K and 10-Q, which identify material risk factors that could cause actual results to differ from those contained in forward-looking statements.

For more information:
Michael Floyd
mfloyd@processapharma.com
(301) 651-4256

Patrick Lin
(925) 683-3218
plin@processapharma.com

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