Profiles of drug substances, excipients, and related methodology最新文献

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. This chapter provides a comprehensive review of avanafil, encompassing its nomenclature, physicochemical properties, methods of preparation, and identification. Various techniques for analysing avanafil, such as electrochemical analysis, spectrophotometric, spectrofluorimetric, and chromatographic techniques, are discussed. The pharmacology of avanafil, including its pharmacokinetics and pharmacodynamics, is also examined.

Duvelisib (DUV) is chemically named as (S)-3-(1-((9H-Purin-6-yl)amino)ethyl)-8-chloro-2-phenylisoquinolin-1(2H)-one. It is a novel drug with a small molecular weight and characterized by dual phosphoinositide-3-kinase (PI3K)- and PI3K-inhibitory activity. The Food and Drug Administration (FDA) recently approved DUV for the management of small lymphocytic lymphoma (SLL) and relapsed or refractory chronic lymphocytic leukemia (CLL) in adult patients. DUV is marketed under the brand name of Copiktra® (Verastem, Inc., Needham, MA, USA). This chapter provides a critical extensive review of the literature, the description of DUV in terms of its names, formulae, elemental composition, appearance, and use in the treatment of CLL, SLL, and follicular lymphoma. The chapter also describes the methods for preparation of DUV, its physical-chemical properties, analytical methods for its determination, pharmacological properties, and dosing information.

Herbal drugs (HD) or traditional drugs have been used worldwide for centuries, especially in the developing countries. Global market of HD reaches billion of USD annually and increases every year. For ensuring the safety and efficacy of HD, the Drug Agency/Authority issues regulations for the registration & application of new HD, their manufacturing processes, controlling and monitoring in the market. The efficacy and safety of HD depend on their whole chemical contents. Quality assessment of HD should be performed using standardization methods according to the current Pharmacopoeias or Materia Medica. Unfortunately, the official methods of the compendia cannot be applied for evaluation of mixed herbs and their preparations.; HD's producers should develop, validate, and standardize the method for the quality assessment of their own specific products. Therefore, assuring the safety and efficacy of HD remains a challenging task due to the complex nature of HD, that typically consist of many constituents of herbs/extracts whose quality may vary among different sources of materials. This present review will describe, compare, and discuss the regulations and standardization methods of HD from US, EU countries, Japan, Taiwan, Hong Kong and Indonesia. The official standardization methods of HD, their current criteria, limitations, challenge and future prospective will be described and discussed. Official methods for quality assessment of HD should be state of the art, fast, low-cost, accurate and precise, and could be used for evaluation of all kinds of HD.

Crizotinib, approved in 2011, was the first approved inhibitor targeting anaplastic lymphoma kinase (ALK) It used for treatment of the patients with metastatic non-small cell lung cancer (NSCLC) that is anaplastic lymphoma kinase (ALK) positive. This chapter provides a complete review of crizotinib including nomenclature, physiochemical properties, methods of preparation, identification techniques and various qualitative and quantitative analytical techniques as well as pharmacology of crizotinib. In addition, the chapter also includes review of several methods for separation of crizotinib using chromatographic techniques.

Lapatinib is an anticancer used for treatment of the patients with advanced metastatic breast cancer in conjunction with the chemotherapy drug capecitabine or with letrozole for the treatment of postmenopausal women with hormone receptor-positive metastatic breast cancer. This comprehensive profile of Lapatinib gives more detailed information about 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 constant of ionization, solubility, X-ray powder diffraction pattern, differential scanning calorimetry, thermal conduct and spectroscopic studies are investigated. The methods employed in bulk medicines and/or in pharmaceutical formulations to analyze the drug substance include spectrophotometric, electrochemical and the chromatographic methods are indicated. Other studies on this drug substance include drug stability, pharmaceutical applications, mechanism of action, pharmacodynamics, and a dosing information are also reviewed.

Remdesivir, marketed under the brand name Veklury, is an antiviral drug with a broad spectrum of activity. There were various countries where the use of Remdesivir for the treatment of COVID-19 was authorized during the pandemic. Remdesivir was first designed to treat hepatitis C, but it was later tested for Ebola virus sickness and Marburg virus infections. Remdesivir is a prodrug designed to facilitate the intracellular transport of GS-441524 monophosphate and its subsequent biotransformation into GS-441524 triphosphate, a ribonucleotide analogue inhibitor of viral RNA polymerase. The objective of this chapter is to provide a comprehensive review of Remdesivir (GS-5734), including its nomenclature, physiochemical properties, preparation methods, identification procedures, numerous qualitative and quantitative analytical techniques, ADME profiles, and pharmacological effects. In addition, the chapter provides a variety of chromatographic and spectroscopic techniques for separating brimonidine from other drugs in combination formulations.

The growth and demand for cosmeceuticals (cosmetic products that have medicinal or drug-like benefits) have been enhanced for the last few decades. Lately, the newly invented dosage form, i.e., the pharmaceutical-based cosmetic serum has been developed and widely employed in various non-invasive cosmetic procedures. Many pharmaceutical-based cosmetic serums contain natural active components that claim to have a medical or drug-like effect on the skin, hair, and nails, including anti-aging, anti-wrinkle, anti-acne, hydrating, moisturizing, repairing, brightening and lightening skin, anti-hair fall, anti-fungal, and nail growth effect, etc. In comparison with other pharmaceutical-related cosmetic products (creams, gels, foams, and lotions, etc.), pharmaceutical-based cosmetic serums produce more rapid and incredible effects on the skin. This chapter provides detailed knowledge about the different marketed pharmaceutical-based cosmetic serums and their several types such as facial serums, hair serums, nail serums, under the eye serum, lip serum, hand, and foot serum, respectively. Moreover, some valuable procedures have also been discussed which provide prolong effects with desired results in the minimum duration of time after the few sessions of the serum treatment.

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 quantitative analytical techniques, as well as its ADME profiles and pharmacological effects. In addition, the chapter contains numerous approaches for separating brimonidine from other medications in combination formulations utilizing chromatographic techniques and other spectroscopic approaches.