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Pediatric Drug Development: Reviewing Challenges and Opportunities by Tracking Innovative Therapies.

The paradigm of pediatric drug development has been evolving in a "carrot-and-stick"-based tactic to address population-specific issues. However, the off-label prescription of adult medicines to pediatric patients remains a feature of clinical practice, which may compromise the age-appropriate evaluation of treatments. Therefore, the United States and the European Pediatric Formulation Initiative have recommended applying nanotechnology-based delivery systems to tackle some of these challenges, particularly applying inorganic, polymeric, and lipid-based nanoparticles. Connected with these, adv

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… Moreover, the choice of excipients for pediatric drug formulation has been questioned as certain excipients used in adult drug formulation are not adequate for pediatric use, with toxicological risks and safety issues in children [ 13 ]. … Moreover, assessing the safety of excipients used in the formulation of pediatric pharmacotherapy is crucial. 3.2.5. Excipients Excipients are important constituents of medicines that are anticipated to have no direct biological or therapeutic effect [ 110 ]. …

Efficacy of local budesonide therapy in the management of persistent hyposmia in COVID-19 patients without signs of severity: A structured summary of a study protocol for a randomised controlled trial.

OBJECTIVES: To assess the efficacy of local intranasal treatment with budesonide (nasal irrigation), in addition to olfactory rehabilitation … rticipate in the study. Non-inclusion criteria - Known hypersensitivity to budesonide or any of the excipients; - Hemostasis disorder or epistaxis; - Oral-nasal and ophthalmic herpes virus infection; - Long-term corticosteroid treatment; - Treatment with potent CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, voriconazole, posaconazole, clarithromycin, t …

Perindopril: A comprehensive profile.

Perindopril (PER) is classified as angiotensin-converting enzyme (ACE) inhibitors and is used primarily for the management of hypertension and cardiovascular conditions, including heart failure and stable coronary artery disease. Two primary salts of PER have been developed, perindopril arginine (PER-Arg) and perindopril erbumine (PER-E). This chapter presents a detailed overview on the physicochemical attributes of PER-Arg, molecular structure, synthetic pathway, crystallographic behavior, thermal stability, and UV absorbance profile of PER-Arg. Moreover, the chromatographic, spectrophotometr

Sofosbuvir: A comprehensive profile.

Sofosbuvir, a nucleotide analogue, is an antiviral medication that belongs to the class of direct-acting antivirals (DAAs). It is primarily used in the treatment of chronic hepatitis C virus (HCV) infections. Sofosbuvir works by inhibiting the replication of HCV, disrupting its ability to produce RNA and effectively reducing the viral load in the body. This chapter offers a comprehensive examination of sofosbuvir, including its nomenclature, physiochemical attributes, synthesis, and thermal analysis. Furthermore, it presents various analytical methods employed for both spectrophotometric and c

Avanafil: A comprehensive drug profile.

Avanafil is an oral medication used to treat erectile dysfunction (ED). As a phosphodiesterase type 5 (PDE5) inhibitor, it functions by inhibiting the PDE5 enzyme, which ultimately results in increased levels of cyclic guanosine monophosphate (cGMP) and improved blood flow to the penis. Approved by the FDA in 2012, avanafil is recognised for its rapid onset of action, short half-life, and favourable side-effects profile. While it has been explored for other potential therapeutic applications, its current approved use is limited to ED and should be used as prescribed by a medical professional.

Brimonidine.

Brimonidine is a highly selective 2-adrenoceptor agonist that lowers intraocular pressure (IOP) by decreasing aqueous humor production and increasing aqueous humor outflow via the uveoscleral route. Brimonidine is used to treat glaucoma and other eye conditions. Brimonidine is a topical medication that is used mainly to treat open-angle glaucoma and ocular hypertension in the eyelids. The purpose of this chapter is to provide a comprehensive discussion of Brimonidine's nomenclature, physiochemical properties, preparation methods, identification procedures, and numerous qualitative and quantita

Ticagrelor.

Ticagrelor is one of the most recent antiplatelet agents used to inhibit platelet aggregation via blocking the ADP receptors of the subtype P2Y12. It belongs to the non-thienopyridine class. The drug was first discovered by Astra Zeneca and approved for use in 2011 by the FDA. Ticagrelor is usually used for the prevention and treatment of thromboembolism in adult patients with acute coronary syndrome. This chapter include an overview on the physical properties, chemical properties, mode of action, pharmacokinetics and common uses of ticagrelor. In addition, the reported methods of ticagrelor a

Azilsartan medoxomil.

Azilsartan is used for treatment of the high blood pressure (hypertension). Reducing high blood pressure enables avoid strokes, heart attacks and problems of kidneys. Azilsartan comes under the name angiotensin receptor blocker (ARBs) as a class of drugs. It acts by relaxing blood vessels to make it easier for blood to flow. Azilsartan Medoxomil's a comprehensive profile containing the description, formulae, Elemental Analysis, Uses and application. Furthermore, methods and schemes are outlined for the preparation of the drug substance. The physical properties of the medication include constan

Meloxicam.

Meloxicam, an oxicam derivative: 4-Hydroxy-2-methyl-N-(5-methyl-2-thiazolyl)-2H-1,2- benzothiazine-3-carboxamide 1,1-dioxide, is a nonsteroidal anti-inflammatory drug (NSAID). It is a selective inhibitor of cyclooxygenase-2 (COX-2). It is used in the management of rheumatoid arthritis, acute exacerbations of osteoarthritis, ankylosing spondylitis and juvenile idiopathic arthritis. It is given in a single oral dose of 7.5mg, increased if necessary to a maximum of 15mg daily (7.5mg in the elderly). It may also be given by rectal suppository in doses similar to those used orally. The reported sid

Gliclazide.

Gliclazide is a second-generation oral hypoglycemic drug used for the treatment of noninsulin-dependent diabetes mellitus. It belongs to the sulfonylurea class that stimulates insulin secretion from pancreatic β-cells by inhibiting ATP-dependent potassium channels. Gliclazide also possesses unique antioxidant properties and other beneficial hemobiological effects. This profile represents a comprehensive description of the physical properties, chemical synthesis, spectroscopic characterization (FTIR, 1H NMR, 13C NMR, UV, and single-crystal X-ray), methods of analysis, pharmacological actions, a

Olmesartan.

Olmesartan is an angiotensin receptor blockers with actions similar to those of losartan; it is used for the treatment of high blood pressure by relaxing blood vessels for this reason blood can flow more easily. It could be used alone or in combination with other antihypertensive drugs. This chapter gives a comprehensive profile of olmesartan, containing detailed nomenclature, formulae, elemental analysis, and appearance of the drug. In addition this chapter also describes several methods of synthesis and usage of the olmesartan. The profile covers the physicochemical properties including pKa

Propranolol.

Propranolol is a noncardioselective β-blocker. It is reported to have membrane-stabilizing properties, but it does not own intrinsic sympathomimetic activity. Propranolol hydrochloride is used to control hypertension, pheochromocytoma, myocardial infarction, cardiac arrhythmias, angina pectoris, and hypertrophic cardiomyopathy. It is also used to control symptoms of sympathetic overactivity in the management of hyperthyroidism, anxiety disorders, and tremor. Other indications cover the prophylaxis of migraine and of upper gastrointestinal bleeding in patients with portal hypertension. This stu

Cinnarizine: Comprehensive Profile.

Cinnarizine is a piperazine derivative with antihistaminic, antiserotonergic, antidopaminergic, and calcium channel-blocking activities. A comprehensive profile was performed on cinnarizine including its description and the different methods of analysis. The 1H NMR and 13C one- and two-dimensional NMR methods were used. In addition, infrared and mass spectral analyses were performed which all confirmed the structure of cinnarizine.

Imatinib mesylate.

Imatinib (INN), marketed by Novartis as Gleevec (United States) or Glivec (Europe/Australia/Latin America), received Food & Drug Administration (FDA) approval in May 2001 and is a tyrosine kinase inhibitor used in the treatment of multiple cancers, most notably Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia. Like all tyrosine kinase inhibitors, imatinib works by preventing a tyrosine kinase enzyme. Because the BCR-Abl tyrosine kinase enzyme exists only in cancer cells and not in healthy cells, imatinib works as a form of targeted therapy-only cancer cells are killed throug

Vardenafil dihydrochloride.

Vardenafil (VAR) is synthetic, highly selective, and potent inhibitor of phosphodiesterase-5 which competitively inhibits cyclic guanosine monophosphate (cGMP) hydrolysis and thus increases cGMP levels. It is clinically approved for treatment of erectile dysfunction in men, including diabetic and postprostatectomy patients. Several methods of VAR synthesis are included in this review. UV spectroscopy of VAR showed a λmax of approximately 270nm, and IR spectroscopy principal peaks were observed at 3420 (NH), 1724 (CO), 1600 (CC, and CN), 1491 (CHCH) cm(-1). Characteristic carbonyl (CO) carbon w

Melatonin: comprehensive profile.

This chapter includes the aspects of melatonin. The drug is synthesized in the pineal gland starting from tryptophane or synthetically by using indole as starting material. Melatonin has been used as an adjunct to interleukin-2 therapy for malignant neoplasms, as contraceptive, in the management of various forms of insomnia, to alleviate jet lag following long flights, and finally as free radical scavenger and hence as an antioxidant and an anti-inflammatory. The chapter discusses the drug metabolism and pharmacokinetics and presents various method of analysis of this drug such as biological a

Ferulic acid: A comprehensive profile.

Ferulic acid (FA) is a common dietary phenolic compound in various fruits, vegetables, coffee, cereals, and plant-based products. FA is recognized for its potent antioxidant properties and has the potential to be a promising therapeutic agent across various health conditions, including cancer, diabetes, cardiovascular, neurological, and metabolic disorders, viral infections, and skin issues. Therefore, researchers have extensively studied FA and considered it a valuable ingredient for the pharmaceutical, food, and cosmetic industries. This chapter comprehensively reviews FA, covering its nomen

Drugs and polymer based local delivery systems in the treatment of periodontal diseases.

This review explores the innovative approaches in localized drug delivery systems specifically designed to manage periodontal diseases (PD). The primary focus is on how these systems enhance the concentration of therapeutic agents at the site of infection, thereby minimizing systemic side effects and improving treatment outcomes. It emphasizes the role of biodegradable and bioadhesive polymers as carriers for sustained drug release. The chapter reviews different local drug delivery systems, such as fibers, films, chips, microparticles, and gels, highlighting their mechanisms of action, advanta

Rosuvastatin calcium: A comprehensive profile.

Rosuvastatin calcium (Ros-Ca) is a recent addition to the statin class of drugs. It lowers cholesterol levels by inhibiting its production in the liver. It is prescribed to control blood cholesterol levels when diet and exercise fail to manage hypercholesterolemia due to genetic reasons or other health problems. This chapter provides a complete review of Ros-Ca including its physiochemical characteristics, synthesis, and thermal analysis. It also encompasses various analytical approaches for quantitative and qualitative analysis of Ros-Ca.