Explore chapters and articles related to this topic
Quality-by-Design (QbD) for Capsule Formulation and Process Development
Published in Larry L. Augsburger, Stephen W. Hoag, Pharmaceutical Dosage Forms, 2017
Huiquan Wu, Lin Xie, Stephen W. Hoag, Larry L. Augsburger, Mansoor Khan
The binary powder mixture can be classified into two categories: (1) minimal ST if an L/F ratio equal to or close to one is obtained, in which case the powder mixture is stable and more likely to maintain uniformity under free-flowing conditions; (2) strong ST if an L/F ratio deviates from 1 significantly, in which case the tested powder mixture is unstable and the blend is prone to segregate.
Introduction
Published in Dilip M. Parikh, Handbook of Pharmaceutical Granulation Technology, 2021
Processing powders in the industry is a challenge. Particularly in the chemical and pharmaceutical industries as different powders are mixed there to make a solid dosage form such as tablets, capsules, and pellets. It becomes even more critical since the segregation of different ingredients can create a dosage form, which may result in variability in the final product quality attributes. Segregation of powders is due primarily to differences in the size or density or flow properties of the components of the mix. If the product composition has a desirable flow and non-segregating properties, it can be directly compressed or encapsulated. For powder mixture to be homogeneous, the composition of the mix should have complementary physical properties, such as flow, particle size, and morphology. Where drug substance dosage is high and has a poor flow property, and a larger quantity of excipients are needed to facilitate the direct compression, the resulting dosage form may be larger, and thus may not be normally unacceptable due to the difficulty of swallowing such a large tablet. The decision on whether to opt for a granulation operation should also be based on the knowledge of the potential disadvantages associated with employing the direct compression of the powdered mix. Failing these physical attributes, dry or wet granulation should be considered. Granulation is a process of size enlargement used primarily to prepare powders for tableting. It consists of homogeneously mixing the drug and excipients and then wetting them in the presence of a binder so that larger agglomerates or granules are formed. An ideal granulation should contain all the constituents of the mix in the correct proportion in each granule, thus the segregation of the ingredients will not occur.
Risk Perception, Risk Management, and Safety Assessments
Published in Ayodeji Olalekan Salau, Shruti Jain, Meenakshi Sood, Computational Intelligence and Data Sciences, 2022
N. Indumathi, R. Ramalakshmi, N. Selvapalam, V. Ajith
One of the main responsibilities of the employer is the implementation of Occupational Safety and Health Act 1994 to protect the public and employees from the detrimental effects of chemical substances spread out inside the premises of the industry. A chemical fitness hazard evaluation (CHRA) on chemical use is performed periodically to evaluate the workers’ physical fitness (Husin et al., 2012). The use of chemicals in the fireworks industry is inevitable and leads to many hazards such as fire and explosion, and occupational hazards and injuries such as chemical skin burns, respiratory diseases, reproductive problems, and even death (Freivalds and Johnson, 1990). Burning of waste products of the fireworks industries may produce carbon monoxide. Although there is less possibility of exposure to these smokes for the workers, if they get exposed to carbon monoxide, it may find its way to the bloodstream through inhalation and would lead to carboxyhemoglobin formation in the bloodstream. Continuous production of carboxyhemoglobin would lead to headache, damage to the central nervous system, and eventually death (Poulton and Kosanke, 1995). Similarly, at the explosion of fireworks, particles of metals such as iron and copper may have the possibility to enter the inner sections of the cornea, which will result in retinal trauma, cataract formation, and glaucoma (Al-Tamimi, 2014). The atmospheric contaminations in the form of particles are any form of risk quotients, risk indices, and cancer risks are by the particulate matter of PM10. Although there are many other air pollutants that can cause breathing problems, cardiovascular problems, bronchitis, lung infection, lung fibrosis, deep vein thrombosis, and lung cancer. PM and other pollutants, such as O3 and NO2, are more likely to cause these unfavourable outcomes (Chalvatzaki et al., 2019). Fireworks industry uses flash powder. The flash powder mixture is highly sensitive and produces electrostatic discharge and friction. Flash powder mixture is highly likely to lead accidents and also illness (Azhagurajan, and Selvakumar, 2014). Dust explosions are a frequent hazard in pyrotechnics industries and other industrial environments. Dust explosions are one of the causes of mortality, contamination, and adverse environmental effects. A flammable dust is any quality material that has the potential to seize hearth and explode when mixed with air. The waste disposal of chemical mixing produces lots of dirt or pollution to the surroundings (Taveau, 2014). Exposure to these chemicals often results in various short- and long-term health problems such as poisoning, pores and skin rashes, and disorders of the lung, kidney, and liver (Gouder and Montefort, 2014).
Pyrimethamine 3D printlets for pediatric toxoplasmosis: design, pharmacokinetics, and anti-toxoplasma activity
Published in Expert Opinion on Drug Delivery, 2023
Ziyaur Rahman, Tahir Khuroo, Eman M Mohamed, Sathish Dharani, Canberk Kayalar, Mathew A. Kuttolamadom, Lamba Omar Sangaré, Mansoor A. Khan
PMT printlets were successfully printed using design of experiment method with dose flexibility potential. Hardness and disintegration of the printlets were statistically affected by laser scanning speed (p < 0.05) while dissolution was affected by disintegrant percentage (p < 0.05) in the composition. Thermal and diffractogram data indicated phase transformation of the crystalline drug into amorphous form during printing process. Most important factors causing that transformation were the laser scanning speed and thermoplastic polymer content in the composition. Powder mixture exposed to printing process also showed some degree of phase transformation of the drug and an increase in particle size distribution that may impact recyclability of the powder. Pharmacokinetic profiles and cell line activity of printlets and the compressed tablets were similar (p > 0.05). It is expected that no clinical differences will be observed between the printlets and the compressed tablets.
Effect of functional excipients on the dissolution and membrane permeation of furosemide formulated into multiple-unit pellet system (MUPS) tablets
Published in Pharmaceutical Development and Technology, 2022
C. J. Van der Merwe, J. D. Steyn, J. H. Hamman, W. Pheiffer, H. Svitina, B. Peterson, J. H. Steenekamp
The excipients and furosemide (active ingredient) for each formulation as specified in Table 1 were mixed using a Turbula T2B (WA Bachofen, Muttenz, Switzerland) mixer at 69 rpm for 5 min. The mixed powder blends (100 g) were then transferred to a porcelain mortar and wetted with a wetting liquid (i.e. water:ethanol = 1:1). A pestle was then used to mix the powder while the wetting liquid was added slowly to the powder mixture. The bead preparation process commenced with extrusion of the wetted powder mass of each formulation with an Extruder 20 (Caleva®, Sturminster Newton, UK) through screens with different size openings for each bead size (i.e. 0.5, 0.75, and 1.0 mm, respectively). The extrusion step was followed by spheronisation of the extrudate in a multi-bowl spheroniser (Caleva®, Sturminster Newton, UK). The beads were freeze-dried for 48 h using a VirTis® bench top freeze drier (SP Industries Company, Warminster, PA). The freeze dried beads were then stored in a screw top glass bottle in a dark, cool, dry place until needed for further study.
Enhancing flowability of fine cohesive active pharmaceutical ingredients
Published in Drug Development and Industrial Pharmacy, 2021
Fine powders often have to be further processed and various techniques/solutions have been developed to tackle poor flowability. Glidants or flow aids are used as one of the solutions to improve flowability. Particles of the glidant or flow aid powder are of the same size or can be smaller than the primary powder particles. Improvement in the flowability of the resultant powder mixture can be seen when fine cohesive powder particles of the micrometer size range are mixed with powder particles having bigger or similar sized particles having good flowability. Powder particles with particle size in the nanometer range used as flow aids are commonly referred to as guest particles and the primary powder particles are referred to as host particles. The host particle surfaces are covered with guest particles [13–15]. The guest particles can improve the flowability of the host particles if they adhere to the surfaces of the latter. The flowability improvement is brought about by the mitigation of the van der Waals forces which is the consequence of the increase in inter-particle distance between host particles by nanoparticles. Surface roughness, shape of the particle, particle size, acquired charge, surface chemistry, hydrophilicity, hydrophobicity, and atoms orientation in the surface are some of the factors influencing the improvement in the flow of the powders [14–19].