Oral Prednisolone for Acute Rhinovirus Induced Wheezing in Children Less Than 2 Years of Age: a Point-of-care Testing Guided Randomized, Double-blind, Placebo-controlled Trial

The aim of the trial is to evaluate whether the use of oral prednisolone directed by point-of-care testing is useful in acute wheezing caused by rhinovirus in children aged 6-24 months.

Start Date11 Oct 2022

Sponsor / Collaborator

University of Oulu

CTR20220992 / Active, not recruitingPhase 3

一项在年龄 ≥ 2岁至 < 18岁、初治、能独坐但无法行走的迟发型2型脊髓性肌萎缩症（SMA）患者中评价鞘内（IT）注射OAV101的疗效和安全性的随机、假操作对照、双盲研究

[Translation] A randomized, sham-controlled, double-blind study to evaluate the efficacy and safety of intrathecal (IT) OAV101 in treatment-naïve patients with late-onset type 2 spinal muscular atrophy (SMA) aged ≥ 2 years to < 18 years who are able to sit independently but cannot walk

这是一项III期、多中心、单次给药（1.2x10^14载体基因组）、随机化、假操作对照、双盲试验，目的是评估鞘内（IT）注射OAV101在≥2岁至<18岁的携带SMN1双等位基因致病突变和2-4个SMN2拷贝的初治、能独坐但无法行走的2型SMA患者中的安全性、耐受性和疗效。

[Translation]

This is a Phase III, multicenter, single-dose (1.2x10^14 vector genomes), randomized, sham-controlled, double-blind trial designed to evaluate the safety, tolerability, and efficacy of intrathecal (IT) OAV101 in treatment-naïve patients aged ≥2 to <18 years with type 2 SMA who are able to sit independently but cannot walk and carry biallelic pathogenic mutations in SMN1 and 2-4 copies of SMN2.

Start Date23 Jun 2022

Sponsor / Collaborator

China Novartis Institutes for BioMedical Research Co., Ltd.

[+2]

NCT03491098 / Unknown statusEarly Phase 1IIT

The Efficacy of Nasal Steroids in Treatment of Otitis Media With Effusion: Acomparative Study

Otitis media with effusion (OME) is defined as effusion in the middle ear without signs and symptoms of an acute infection. It is a leading cause of hearing impairment in children, and its early and proper management can avoid hearing and speech impairment, which can cause developmental delay in children.Although many conditions such as enlarged adenoids, cleft palate, Down syndrome, Kartagener syndrome, and nasopharyngeal neoplasm are related to the role of eustachian tube (ET) dysfunction in the pathogenesis of OME, allergic, immunologic, and infectious factors have also been claimed. Treatment of OME is still a controversial issue, as conventional treatment approaches fail to provide satisfactory and permanent relief of otologic symptoms.There is lack of proven effectiveness of the commonly given treatments, such as antibiotics, decongestants, and antihistamines, which are potentially harmful and have disadvantages. Few in those studies,investigated topical intranasal steroid for OME treatment,and in those studies, the duration of intranasal steroid application was short and there was no hearing evaluation.

Start Date15 May 2018

Sponsor / Collaborator

Assiut University

100 Clinical Results associated with Prednisolone Sodium Phosphate

100 Translational Medicine associated with Prednisolone Sodium Phosphate

100 Patents (Medical) associated with Prednisolone Sodium Phosphate

197

Literatures (Medical) associated with Prednisolone Sodium Phosphate

01 Apr 2025·DEN open

Duodenitis associated with ulcerative colitis and pouchitis after total colectomy successfully treated with upadacitinib: A case report

Article

Author: Tezuka, Yukari ; Kojima, Kentaro ; Onishi, Sachiyo ; Shimizu, Masahito ; Masuda, Naoya ; Otani, Kiichi ; Takada, Jun ; Kubota, Masaya ; Ibuka, Takashi

Abstract:

A 27‐year‐old man had ulcerative colitis (UC) 1 year prior and underwent a colectomy and two‐stage ileal pouch‐anal anastomosis for medically refractory UC 6 months ago. He visited our department with epigastric pain and discomfort, increased stool frequency, and bloody diarrhea. Esophagogastroduodenoscopy revealed continuous diffuse friable mucosa, erosions, and edema in the duodenum, and pouchoscopy revealed multiple ulcers and purulent mucus adhesions. Based on endoscopic and pathological findings, the patient was diagnosed with duodenitis associated with UC and pouchitis, for which he received oral prednisolone (40 mg/day) and ciprofloxacin. The frequency of stools and occurrence of bloody diarrhea reduced, and epigastric pain and discomfort improved after 2 weeks. However, when prednisolone was discontinued, the symptoms worsened, albumin level decreased, and C‐reactive protein level increased. Following this, we administered a 20 mg prednisolone sodium phosphate enema once daily, and the patient's symptoms improved. However, the symptoms relapsed when the enema was discontinued. Assuming that the patient had steroid‐dependent duodenitis associated with UC and pouchitis, we initiated upadacitinib. His symptoms improved within a few days, and biomarkers returned to normal after 1 month. Nine months after initiating the upadacitinib treatment, endoscopic remission was achieved in the mucosa of the duodenum and pouch. The patient has been in clinical remission for 1 year without any adverse events.

01 Dec 2024·International Journal of Pharmaceutics-X

Ocular mucoadhesive and biodegradable spanlastics loaded cationic spongy insert for enhancing and sustaining the anti-inflammatory effect of prednisolone Na phosphate; Preparation, I-optimal optimization, and In-vivo evaluation

Article

Author: Ali, Khaled M ; Zaki, Randa Mohammed ; Said, Mayada ; Afzal, Obaid ; Aldosari, Basmah Nasser ; Ali, Khaled M. ; Alfadhel, Munerah M. ; Bafail, Rawan ; Alfadhel, Munerah M ; Alsunbul, Maha

This study aimed to formulate and statistically optimize spanlastics loaded spongy insert (SPLs-SI) of prednisolone Na phosphate (PRED) to enhance and sustain its anti-inflammatory effect in a controlled manner. An I-optimal optimization was employed using Design-Expert® software. The formulation variables were sonication time, the Span 60: EA ratio and type of edge activator (Tween 80 or PVA) while Entrapment efficiency (EE%), Vesicles' size (VS) and Zeta potential (ZP) were set as the dependent responses. This resulted in an optimum spanlastics (SPLs) formulation with a desirability of 0.919. It had a Span60:Tween80 ratio of 6:1 with a sonication time of 9.5 min. It was evaluated in terms of its EE%, VS, ZP, release behavior in comparison to drug solution in addition to the effect of aging on its characteristics. It had EE% of 87.56, VS of 152.2 nm and ZP of -37.38 Mv. It showed sustained release behavior of PRED in comparison to drug solution with good stability for thirty days. TEM images of the optimized PRED SPLs formulation showed spherical non-aggregated nanovesicles. Then it was loaded into chitosan spongy insert and evaluated in terms of its visual appearance, pH and mucoadhesion properties. It showed good mucoadhesive properties and pH in the safe ocular region. The FTIR, DSC and XRD spectra showed that PRED was successfully entrapped inside the SPLs vesicles. It was then exposed to an in-vivo studies where it was capable of enhancing the anti-inflammatory effect of PRED in a sustained manner with once daily application compared to commercial PRED solution. The spongy insert has the potential to be a promising carrier for the ocular delivery of PRED.

01 Oct 2024·JOURNAL OF CONTROLLED RELEASE

A bio-predictive release assay for liposomal prednisolone phosphate

Article

Author: Nagpal, Shakti ; Png, Jordan ; Kahouadji, Lyes ; Wacker, Matthias G

Predictive performance assays are crucial for the development and approval of nanomedicines and their bioequivalent successors. At present, there are no established compendial methods that provide a reliable standard for comparing and selecting these formulation prototypes, and our understanding of the in vivo release remains still incomplete. Consequently, extensive animal studies, with enhanced analytical resolution for both, released and encapsulated drug, are necessary to assess bioequivalence. This significantly raises the cost and duration of nanomedicine development. This work presents the development of a discriminatory and biopredictive release test method for liposomal prednisolone phosphate. Using model-informed deconvolution, we identified an in vivo target release. The experimental design employed a discrete L-optimal configuration to refine the analytical method and determine the impact of in vitro parameters on the dosage form. A three-point specification evaluated the key phases of in vivo release: early (T-5%), intermediate (T-20%), and late release behavior (T-40%), compared to the in vivo release profile of the reference product, NanoCort®. Various levels of shear responses and the influence of clinically relevant release media compositions were tested. This enabled an assessment of the effect of shear on the release, an essential aspect of their in vivo deformation and release behavior. The type and concentration of proteins in the medium influence liposome release. Fetal bovine serum strongly impacted the discriminatory performance at intermediate shear conditions. The method provided deep insights into the release response of liposomes and offers an interesting workflow for in vitro bioequivalence evaluation.

News (Medical) associated with Prednisolone Sodium Phosphate

17 Apr 2023

·www.drugs.com

Get Pain Relief With the Most Common Arthritis Medications

MONDAY, April 17, 2023 -- Arthritis is a common disease that causes pain and inflammation in different body joints, making it difficult to enjoy everyday tasks and physical activity. Fortunately, there are many different medications for arthritis. Depending on what type of arthritis you have and its severity, an arthritis medication may help you manage pain and other symptoms. Here is a breakdown of the most common arthritis medications, how they work and their potential side effects. The Arthritis Foundation lists the following as the medications used to treat arthritis: Analgesics including acetaminophen (Tylenol) and opioids Nonsteroidal anti-inflammatory drugs (NSAIDs) Corticosteroids Disease-modifying antirheumatic drugs (DMARDs) including biologics and targeted DMARDs Analgesics The Arthritis Foundation reports that analgesics may help with mild to moderate pain, but they will not help with the inflammation associated with arthritis. Analgesics work in the nervous system and alter how your brain perceives pain. They can be used to treat the pain associated with any type of arthritis, although more effective options are available. Analgesics can be opioid, non-opioid or a combination. Common analgesics are: Acetaminophen (Tylenol) Codeine Oxycodone Fentanyl Hydrocodone Potential side effects: Kidney damage Liver damage Addiction Constipation Gastrointestinal bleeding Use caution when taking these medications; take only as prescribed. NSAIDs NSAIDs work by blocking prostaglandin. According to the Cleveland Clinic , one role prostaglandins play is forming clots and causing inflammation at the site of an injury. NSAIDs are used to treat the pain and inflammation associated with rheumatoid arthritis and osteoarthritis . Common over-the-counter (OTC) NSAIDs are: Aspirin (Bayer, St. Joseph, Anacin, Excedrin and more) Ibuprofen (Motrin, Advil) Naproxen sodium (Aleve) Prescription NSAIDs are: Celecoxib (Celebrex) Diclofenac (Voltaren, available by brand name in topical form) Fenoprofen (Nalfon) Indomethacin (Indocin, available by brand name in liquid form) Ketorolac tromethamine (Toradol) Meclofenamate sodium (Meclomen) Diflunisal (Dolobid) Tolmetin (Tolectin) Ketoprofen (Orudis) Flurbiprofen (Ansaid) Potential side effects of NSAIDs are: Increased risk of stomach and bowel issues like ulcers and bleeding Increased risk of stroke Heart problems Stomach pain Nausea Diarrhea/constipation Corticosteroids According to the Arthritis Foundation , corticosteroids mimic cortisol, a hormone your body produces naturally. They are used to treat inflammatory types of arthritis, including rheumatoid arthritis and psoriatic arthritis. They are great for short-term relief of inflammation but are not recommended for long-term use because of their side effects. Your doctor may prescribe a lower dose if you require them for long-term use. Common corticosteroids: Prednisone (Deltasone, Prednicot, Cotolone) Prednisolone (Orapred, Omnipred) Cortisone (Cortone) Hydrocortisone (Cortef, Hydrocort) Triamcinolone (Aristocort) Dexamethasone (Decadron) Common side effects of corticosteroids: Blood sugar spikes Weight gain Bone loss Risk of cataracts High blood pressure Infections Mood changes DMARDs The Arthritis Foundation says that DMARDs work with the body to “stop or slow the disease process in inflammatory forms of arthritis.” They work by blocking inflammation. There are many different DMARDs on the market, and they all have different ways of working in the body. Conventional DMARDs work by broadly suppressing the immune system. Often they are used in combination with other therapies. Targeted DMARDs block specific pathways inside immune cells. Biologic DMARDs are produced by live cells and work on specific immune proteins called cytokines. Common DMARDs: Apremilast (Otezla) Baricitinib (Olumiant) Cyclophosphamide (Cytoxan) Cyclosporine (Gengraf, Neoral) Hydroxychloroquine (Plaquenil) Leflunomide (Arava) Methotrexate (Otrexup, Rasuvo, RediTrex) Mycophenolate mofetil (CellCept) Sulfasalazine (Azulfidine) Tofacitinib (Xeljanz, Xeljanz XR) According to the Cleveland Clinic , common side effects of traditional DMARDs include: Loss of appetite Nausea Diarrhea Abdominal pain Rash, allergic reaction Liver problem Increased risk of infection Low blood cell counts Common side effects of biologic DMARDs include: Increased risk of common and serious infections Reactivation of tuberculosis, herpes zoster, and hepatitis B and C Increased cholesterol levels, increased liver enzymes and low blood cell counts Increased risk of clotting When prescribed DMARDs, inform your doctor of any other medications, including over-the-counter medicines, you are taking to avoid drug interactions. Some of these medications can cause teratogenicity (defects in a developing fetus.) Writing recently in the Journal of the American Academy of Physician Assistants (JAAPA ), physician assistant Michelle DiBiase and Dr. Samantha Kohn remind people that "The mainstay of pharmacologic therapy is early intervention with use of nonbiologic and biologic DMARDs together with adjunctive medications such as NSAIDs, oral and intra-articular corticosteroids, and analgesic medications, including opioids." Your primary care provider or rheumatologist will work closely with you to determine which medications are best for your treatment. It is vital to keep them apprised of any side effects and let them know if the treatment is ineffective. They can work with you to find a treatment that helps relieve the pain and inflammation caused by arthritis. Posted April 2023

Drug Approval

10 Oct 2012

·www.biospace.com

Mylan Inc. Announces Settlement Agreement for Its First-to-File Generic Version of Orapred ODT&#0174

PITTSBURGH, Oct. 9, 2012 /PRNewswire/ -- Mylan Inc. (Nasdaq: MYL) today announced that it has entered into a settlement agreement with Shionogi Inc. and CIMA Labs Inc. that will resolve patent litigation related to Prednisolone Sodium Phosphate Orally Disintegrating Tablets (ODT), 10 mg, 15 mg and 30 mg. Prednisolone Sodium Phosphate ODT is the generic version of Shionogi's Orapred ODT®, which is indicated for the treatment of certain pulmonary diseases such as asthma. Additionally, the product is indicated for the control of certain severe or incapacitating allergic conditions, such as atopic dermatitis, and seasonal and perennial allergic rhinitis, that are intractable to adequate trials of conventional treatment. According to the terms of the settlement, Mylan will be licensed to sell its Prednisolone Sodium Phosphate ODT product on April 1, 2014, or earlier under certain circumstances. Pursuant to the agreement, pending litigation will be dismissed. Other details of the settlement are confidential, and the agreement itself is subject to review by the U.S. Department of Justice and the Federal Trade Commission. Mylan believes it was the first company to have filed a substantially complete abbreviated new drug application (ANDA) containing a Paragraph IV certification with the U.S. Food and Drug Administration (FDA) for Prednisolone Sodium Phosphate ODT, 10 mg, 15mg and 30 mg, and anticipates that it will be entitled to 180 days of generic market exclusivity. This product had U.S. sales of $33.1 million for the 12 months ending June 30, 2012, according to IMS Health. This press release includes statements that constitute "forward-looking statements," including with regard to the settlement of the litigation and sales of the product. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: any legal or regulatory challenges to the settlement; strategies by competitors or other third parties to delay or prevent product introductions; risks inherent in legal and regulatory processes; and the other risks detailed in the company's periodic filings with the Securities and Exchange Commission. The company undertakes no obligation to update these statements for revisions or changes after the date of this release. Mylan is a global pharmaceutical company committed to setting new standards in health care. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service a habit, do what's right, not what's easy and impact the future through passionate global leadership. We offer a growing portfolio of more than 1,100 generic pharmaceuticals and several brand medications. In addition, we offer a wide range of antiretroviral therapies, upon which approximately one-third of HIV/AIDS patients in developing countries depend. We also operate one of the largest active pharmaceutical ingredient manufacturers and currently market products in approximately 150 countries and territories. Our workforce of more than 18,000 people is dedicated to improving the customer experience and increasing pharmaceutical access to consumers around the world. But don't take our word for it. See for yourself. See inside. mylan.com SOURCE Mylan Inc.

Collaborate

100 Deals associated with Prednisolone Sodium Phosphate

External Link

KEGG	Wiki	ATC	Drug Bank
D00981	Prednisolone Sodium Phosphate	D07XA02 D07AA03 S02BA03	DB14631

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Edema	US	Concordia Pharmaceuticals, Inc.	01 Jun 2006
Endocrine System Diseases	US	Concordia Pharmaceuticals, Inc.	01 Jun 2006
Eye Diseases	US	Concordia Pharmaceuticals, Inc.	01 Jun 2006
Gastrointestinal Diseases	US	Concordia Pharmaceuticals, Inc.	01 Jun 2006
Hematologic Diseases	US	Concordia Pharmaceuticals, Inc.	01 Jun 2006
Multiple Sclerosis	US	Concordia Pharmaceuticals, Inc.	01 Jun 2006
Skin Diseases	US	Concordia Pharmaceuticals, Inc.	01 Jun 2006
Colitis, Ulcerative	JP	KYORIN Pharmaceutical Co., Ltd.	14 Mar 2002
Enteritis	JP	KYORIN Pharmaceutical Co., Ltd.	14 Mar 2002
Anaphylaxis	US	Seton Pharmaceuticals LLC	28 May 1986
Neoplasms	US	Seton Pharmaceuticals LLC	28 May 1986
Respiratory Diseases	US	Seton Pharmaceuticals LLC	28 May 1986
Rheumatic Diseases	US	Seton Pharmaceuticals LLC	28 May 1986

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Rheumatoid Arthritis	Phase 3	NL	Sun Pharmaceutical Industries Ltd.	21 Nov 2015
Graves Ophthalmopathy	Phase 2	NL	-	13 Jul 2017
Arteriovenous Fistula	Phase 2	NL	-	13 Oct 2015
Ocular inflammation	Phase 2	US	Evolutec Group Plc	17 Jul 2006

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


Phase III Study (EULAR2019)	Phase 3	-	172	Intravenous Pegylated Liposomal Prednisolone Sodium Phosphate 75 mg	ntjgvnihyn(gcosbuqfwa) = wnlxzrrbfb fsuskcewtn (ckngkquifb )	Positive	12 Jun 2019
				Intravenous Pegylated Liposomal Prednisolone Sodium Phosphate 150 mg	ntjgvnihyn(gcosbuqfwa) = urdrexvakv fsuskcewtn (ckngkquifb )
SCUT (ARVO2006)	Not Applicable	Corneal Ulcer	-	Antibiotics and Placebo	jvjvyimgip(ouxmglfvya) = clhkbbwxep dzxmxfutky (rkvkmqpjkp ) View more	-	01 May 2006
				Prednisolone phosphate	jvjvyimgip(ouxmglfvya) = cstzysqzye dzxmxfutky (rkvkmqpjkp )

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