A Model- Based Methodology for Spray Drying Process Development
Journal of Pharmaceutical Innovation September 2009 Volume 4 Issue 3
This paper describes a novel methodology based on fundamental engineering models as well as process characterization techniques to ensure that the spray drying process is efficient and requires minimal time and API. Spray drying methods use rapid drying kinetics to produce solid amorphous dispersions, excipients, and encapsulation. Spray drying dispersions are used to increase bioavailability of poorly soluble APIs. SDDs formulations include polymers that increase stability of the amorphous form so that the solubility of the drug can be increased. This novel methodology has the advantage of minimizing API usages during process development, reducing process development time and ensuring process robustness during technology transfer to clinical manufacturing. This method outlines specific steps based on flow rates, thermodynamics and drying kinetics to produce a more efficient process for spray drying. It is particularly efficient for process development and circumvents the iterative design of experiment (DOE) method for spray drying process development.
The typical spray drying process begins when a spray solution is delivered to an atomizer in a spray drying chamber at the same time as hot drying gas. Spray solutions consist of API and polymers dissolved in a solvent. This solution is atomized into droplets using a spray nozzle. There are an assortment of nozzles that can be used in this process including two-fluid, ultrasonic, rotary, and pressure nozzles. The advantage of using a pressure nozzle is that it allows for scalability and the tuning of droplet size. When droplets from the spray no...
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...ge of physicochemical properties of drugs such as HPMCAS, thus making the first screening step more efficient. This method should also incorporate experiments that correlate the theoretical parameters given by computer models with the parameter actually seen during the process.
Work Cited:
Dobry, D. E., Settell, D. M., Baumann, J. M., Ray, R. J., Graham, L. J., & Beyerinck, R. A. (2009). A Model-Based Methodology for Spray-Drying Process Development. Journal of Pharmaceutical Innovation, 4(3), 133-142.
Friesen, D. T., Shanker, R., Crew, M., Smithey, D. T., Curatolo, W. J., & Nightingale, J. A. (2008). Hydroxypropyl Methylcellulose Acetate Succinate-Based Spray-Dried Dispersions: An Overview. Molecular pharmaceutics, 5(6), 1003-1019.
Vehring, R. (2008). Pharmaceutical Particle Engineering via Spray Drying. Pharmaceutical Research, 25(5), 999-1022.
The purpose of this lab was to investigate which additive(s) will create the longest lasting oil-in-water emulsion.
A self-sterilizing formula is one that either prevents microbial growth (bacteriostatic) or kills-microorganisms (bactericidal /microbicidal).a self –preserving formula may or may not contain antimicrobial preservatives. Relatively anhydrous products (e.g. talcum powder, corn starch, mineral oil, and stick deodorants) do not require preservatives because they do not have sufficient water content to supply microbial growth. However, manufactures may incorporate preservatives in to these products to prevent microbial growth that may occur due to addition of water by consumer during use or abuse. The physicochemical make-up of the product, including low water activity (aw), high or low pH, and multifunctional materials that have antimicrobial properties (e.g. alcohol, surfactants, quaternary ammonium companies) determines whether a formula is self-preserving. Aqueous products in multiuse containers generally require the addition of preservation if they do not prevent microbial growth. The type of packaging and consumer use habits determines the preservation requirements of a
Size and stability: Liquid formulation can be bulky, difficult to transport and store.1 During storage under the stated conditions, it’s necessary that oral solutions are not subject to precipitation, fast sedimentation, caking or formation of lump.2 They have poor stability compare to solid dosage form formulation due to hydrolysis.1 Therefore, it’s important to optimize the active ingredient stability in liquid formulation including those prepared from powder or granules.2
...ticles pack closer together within the paste. Due to the viscosity and hence reduced flow of the binder through the interparticle spaces, the consolidation process is slowed down, effectively delaying any excessive ball growth. This research aims to investigate the granulation mechanisms involved in a high viscous detergent system in order to gain an understanding into how a high viscous binder is dispersed compared to a low viscous binder. This research would not be working with any low viscous binders and would be comparing research results with published work done on low viscous binder granulation systems. Most importantly, the research would focus on effects of process parameters such as binder injection point (literature on which has not been found) and granulation time as well as impeller speed and binder amounts (with considerably more literature published).
Part 4 of this lab showed a way to observe impurities by comparing the melting point of crude and pure samples. Since impurities are to be shown in the crude sample it would have a lower melting point and larger range. The known melting point of aspirin is to be 135 oC. The crude sample had a melting point range from 69oC to 81 oC. While the Pure sample melting point range was from 116oC to 125oC. Since the Pure sample was still below 135 oC, this shows that there are still some impurities
The solubility of HCA in various oils and surfactants such as eucalyptus oil, clove oil, lemon grass oil, pippermint oil, carvone, D-limonene, citronella, menthone, eugenol, oleic acid, tween 20, isopropyl myristate (IPM), tween 80, polyethylene glycol 400 (PEG 400) were measured. An excess amount of HCA was added to 10mL of oil and the mixture was shaken for 72 h at 25 °C. The resulting suspension was then centrifuged (R-8C REMI equipments, Mumbai) for 10 min at 10,000 rpm. The supernatant was filtered through a membrane filter (0.45µm) and the drug concentration in the filtrate was determined by high performance liquid chromatography (HPLC) analysis after appropriate dilution. The oil phase and surfactant that showed high solubility of HCA was used in the preparation of microemulsion.
Where Qt represents the quantity of the dissolved drug in specific time,Kh represents Higuchi dissolution constant while t represents the time. The chart is performed through the proportion of released drug versus thesquare root of time.
Craig, D. Q. (2002). Pharmaceutical Applications of Micro-Thermal Analysis. Journal of Pharmaceutical Science, 91(5), 1201-1213.
Aerogel was discovered in the late 1930’s by chemist Samuel Stephens Kistler. He accomplished this by the process of supercritical fluid drying. A supercritical fluid is any substance at a temperature and pressure above its critical poi...
Through this research I want the community aware of this saponification process and they can learn to make soap with correct ingredient. Hot process method will be used in this experiment to reduce the time needed before the soap can be used (cold process method required six weeks before the soap can be used). I have chosen to make my own soap rather than using commercial soap as it allows me to modify the ingredients for experimental purposes and allow me to acquire new
Hot and Cold Method: this technique is based on the principle that when Bamboo is heated, the air in the cells partially escapes due to expansion. In the course of cooling, preservative makes its way into the cell due to the slight vacuum created upon contraction of residual air. This method permits large scale of Bamboo to
...in bunches, spreading the leaves out like a fan so it can be air dried evenly. The best place to hang them is in a shady open air space. The drying temperature should be consistently around 21C. On average, I find that each plant yields about 0.35% of semi-dried herb. After they finish drying, I store them immediately in airtight glass jars and place them in my storage room.
The reliability of corn starch as an excipient has been trusted since the early days of pharmaceu...
...e, the British Pharmacopeia Finished Drug Product method of analysis in the monograph was taken as granted without being checked for its appropriateness, in this situation Verification should have been carried to check at least the Accuracy, Precision and Specificity of the BP method for the finished product.
Chemical analysis of the drugs being produced in the pharmaceutical industries is very important to ensure that a particular drug is suitable for the purpose it is being made for. Quality control checks include identification tests. In identification tests, we identify the analyte or in other words ensure its identity, by comparing it to some reference standard. This can be done by procedures like chromatographic response.