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Dermal filler complications and management
Published in Michael Parker, Charlie James, Fundamentals for Cosmetic Practice, 2022
Granules are secretory vesicles which are found within the cytoplasm of cells. They act as a storage unit for substances to be used at a later date, and the granule allows them to be kept in an inert manner before being released into the extracellular environment when required.
Binders in Pharmaceutical Granulation
Published in Dilip M. Parikh, Handbook of Pharmaceutical Granulation Technology, 2021
Granulation processes are among the most widely practiced unit processes in oral solid dosage form manufacturing. Granules are an important dosage form in and of themselves; however, most granules are prepared as an intermediate step during tablet and capsule manufacturing. Granulation (also referred to as agglomeration) can be used to improve powder flow properties and reduce fine dust through size enlargement and densification, thus improving tableting operations. Frequently, granulation provides the means to intimately combine a thermoplastic binder with other formulation components, thus improving the compactibility of tablet formulations [1]. In controlled release formulations, granulation is often used to embed the drug in release controlling polymers, thereby retarding dissolution more effectively than a dry blend would. Granulation is also used to prevent powder segregation, thereby ensuring uniform drug distribution. This is especially important in low-dose, high-potency drugs. Lastly, granulation is used to improve the solubility and dispersibility of powders and tablets in water. This may also be referred to as “instantizing” or “hydrophilizing.”
Eosinophils in Airway Hyperresponsiveness
Published in Devendra K. Agrawal, Robert G. Townley, Inflammatory Cells and Mediators in Bronchial Asthma, 2020
Sohei Makino, Takeshi Fukuda, Shinji Motojima, Tatsuo Yukawa
In order to compare the toxic effects of the granule proteins to the airway, Motojima et al.25 cultured tracheal rings from guinea pigs with MBP, ECP, or EPO for 48 h. Native MBP with a reactive sulfhydryl group caused exfoliation of epithelial cells at 10 µg/ml, partial ciliostasis at 50 µg/ml, and complete ciliostasis at 100 µg/ml. ECP at a concentration of 100 µg/ml caused exfoliation of epithelial cells. EDN did not show any appreciable toxicity; EPO at 12 µg/ml only caused exfoliation of epithelial cells, partial ciliostasis at 120 µg/ml, and complete ciliostasis at 1200 µg/ml. When EPO was combined with hydrogen peroxide and iodide, the toxicity was greatly enhanced (approximately fourfold) compared to the toxicity without hydrogen peroxide and iodide. This EPO-induced damage was completely inhibited by catalase and reduced by the deletion of iodide.
Development and characterization of ibuprofen co-crystals granules prepared via fluidized bed granulation in a one-step process – a design of experiment approach
Published in Drug Development and Industrial Pharmacy, 2021
Granulation processes are extensively used in pharmaceutical manufacturing to increase the particle size and improve the flowability of cohesive powders. Granules can be prepared through different methodologies which can be broadly categorized into two types: dry granulation and wet granulation [7]. Among the wet granulation techniques employed, fluidized bed granulation (FBG) is one of the most commonly used in the pharmaceutical industry, and consists of promoting particle agglomeration by spraying a binding solution over particles fluidized by an air or gas stream [8]. However, tight control of both process and formulation variables is needed to guarantee a successful granulation, which is a result of the equilibrium between particles agglomeration and drying [9]. Furthermore, those variables can also have an impact on the solid-state of the active pharmaceutical ingredients (APIs) involved in the granulation process [10].
Preparing of aspirin sustained-release granules by hot-melt granulation and micro-crystal coating
Published in Drug Development and Industrial Pharmacy, 2019
Ran Li, Tian Yin, Yu Zhang, Jingxin Gou, Haibing He, Xing Tang
The change of content of free salicylic acid was showed in Table 2. The h-mG was unstable under high temperatures, with the obvious increase in the content of free salicylic acid and the phenomenon of granules adhesion after 10 days. After 10 days, the granules coated with Eudragit RS/RL30D turned pale yellow and there was a phenomenon of granules adhesion, and the content of free salicylic acid increased obviously. The increase of temperature changed the physical and chemical properties of the aqueous dispersion, reducing the integrity of the coating film, resulting in easy access of water to the interior of granules which led to the hydrolysis of ASP. The effect of high temperature on the release of EC coated granules was not obvious, and the content of free salicylic acid did not change obviously after 10 days. From the results, the effect of high temperature on the granules coated with Eudragit RS/RL30D was more pronounced. Humidity had a small effect on ASP content in m-cG and h-mG. However, with the increase of time, the content of free salicylic acid increased in both m-cG and h-mG. As humidity increased, the water gradually penetrated into the interior of the granules, causing the hydrolysis of ASP by contacting with it. Therefore, ASP sustained-release granules should be stored avoiding excessive humidity. The content of ASP and free salicylic acid in both m-cG and h-mG did not show any change under light tests, indicating ASP sustained-release granules were light-stable.
Safety and efficacy of treatment with lumacaftor in combination with ivacaftor in younger patients with cystic fibrosis
Published in Expert Review of Respiratory Medicine, 2019
Pi Chun Cheng, Stamatia Alexiou, Ronald C. Rubenstein
OrkambiTM is a combination of lumacaftor and ivacaftor, a CFTR modulator indicated for the treatment of CF in patients age 2 years and older who are homozygous for the F508del mutation in the CFTR gene. In patients 12 years and older, it is taken as two tablets (each containing lumacaftor 100mg/ivacaftor 125 mg) orally every 12 h with fat-containing food. In children who weighed less than 14 kg, oral granules (lumacaftor 100mg/ivacaftor 125 mg) every 12 h are recommended. In children who weighted 14 kg or more, oral granules (lumacaftor 150mg/ivacaftor 188 mg) are taken. The oral granules are mixed with 1 teaspoon of soft food or liquid for administration. In two randomized, double-blind, placebo-controlled phase III trials (TRAFFIC and TRANSPORT), lumacaftor/ivacaftor combination therapy was well tolerated by patients aged 12 years and older with CF who were homozygous for the F508del-CFTR mutation and led to improved lung function and body mass index (BMI) and reduced incidence of pulmonary exacerbations, with an acceptable safety profile [5]. The clinical benefits and safety of lumacaftor and ivacaftor for children aged 6–11 and 2–5 are discussed below.