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Morrison, J. T., James Thigpen, Ralph A. Lugo, and Stacy D. Brown. "Stability of Lansoprazole in Oral Suspension." Digital Commons @ East Tennessee State University, 2011. https://dc.etsu.edu/etsu-works/5294.
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Crosby, Jesse, and Stacy D. Brown. "Stability of Compounded Trilostane Suspension in Cod Liver Oil." Digital Commons @ East Tennessee State University, 2017. https://dc.etsu.edu/etsu-works/5313.
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Trilostane is a synthetic steroid analog used to treat canine hyperadrenocorticism. For small dogs, the dose found in commercially available dosage forms of trilostane is sometimes too high. Compounding trilostane in a liquid diluent provides an option for more precise dosing and adjustments, and can be easier to administer, versus a tablet or capsule. Trilostane suspends well in cod liver oil, which is generally palatable to dogs. The stability of a compounded trilostane suspension in cod liver oil stored at room temperature was investigated for 90 days. Compounded trilostane retained stability, defined as maintaining 90–105% labeled value, for 60 days when stored in amber glass bottles. However, drug potency fell >10% below the labeled value when stored in amber plastic bottles after 7 days.
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Brown, Stacy, Jessica Huffman, Amanda Ogle, and Paul Lewis. "Stability of Compounded Pyrimethamine Oral Suspension Stored at Room and Refrigerated Temperature." Digital Commons @ East Tennessee State University, 2016. https://dc.etsu.edu/etsu-works/5270.
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Ali, Shazia. "The adsorption characteristics of the poloxamer surfactants on model hydrophic drugs in suspension systems." Thesis, University College London (University of London), 2001. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.272211.
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Lewis, Paul O., David B. Cluck, Jessica D. Huffman, Amanda P. Ogle, and Stacy D. Brown. "Stability of a Pyrimethamine Suspension Compounded from Bulk Powder." Digital Commons @ East Tennessee State University, 2017. https://doi.org/10.2146/ajhp160551.
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Purpose:Development of a stability-indicating high-performance liquid chromatography (HPLC) method for pyrimethamine analysis, with subsequent application of that method to assess the 90-day stability of a pyrimethamine suspension compounded from bulk USP-grade pyrimethamine powder, is described.
Methods:A stability-indicating method of HPLC with ultraviolet detection specific to pyrimethamine was developed according to pharmacopeial recommendations and validated. The method was applied to investigate the stability of a 2-mg/mL pyrimethamine suspension in a vehicle consisting of Ora-Plus and Ora-Sweet (Perrigo) over a period of 90 days. Three replicate test preparations were stored at room temperature or refrigerated at 4.3–5.2 °C, and samples were analyzed in duplicate immediately after preparation and on study days 1, 2, 4, 7, 10, 14, 21, 30, 48, 60, 75, and 90.
Results:The 2-mg/mL suspension of pyrimethamine in Ora-Plus and Ora-Sweet retained 90–110% of the labeled potency to 90 days at both temperature ranges. However, color changes in the samples stored at room temperature observed at day 60 indicated that a beyond-use date less than 90 days from the preparation date should be specified when the suspension is to be stored at room temperature.
Conclusion:The study demonstrated that USP-grade pyrimethamine powder can be formulated as a 2-mg/mL suspension in a vehicle of Ora-Plus and Ora-Sweet and is stable when stored at room temperature and when refrigerated, in amber plastic bottles, for 48 and 90 days, respectively.
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Jackson, Remonica, Stacy D. Brown, and Paul Lewis. "Comparative Stability of Compounded Omeprazole Suspension Versus Commercial Omeprazole Kit When Stored in Oral Syringes Under Refrigerated Conditions." Digital Commons @ East Tennessee State University, 2019. https://dc.etsu.edu/etsu-works/7847.
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Purpose:Omeprazole is a proton pump inhibitor (PPI) used in the treatment of gastrointestinal conditions, such as gastrointestinal esophageal reflux disease (GERD). Omeprazole is often prepared as an oral suspension to accommodate certain patients. Historically, oral suspensions of omeprazole were prepared using pharmaceutical compounding with sodium bicarbonate, but a kit for preparation of omeprazole oral suspension is available, FIRST® - Omeprazole. The purpose of this project is to compare the stability of the active pharmaceutical ingredient (API), omeprazole, in the FIRST® kit product to a traditionally compounded omeprazole suspension, when stored in refrigerated unit-dosed syringes.
Methods: Five 100-mL batches of compounded omeprazole oral suspension (2 mg/mL) and five 300-mL kits of FIRST® - Omeprazole were prepared by a licensed pharmacist, and aliquoted into 5-mL doses in clear luer-lock plastic oral syringes, and stored at refrigerated temperature (2-8oC). Omeprazole concentration was assessed in each batch/kit on the day of preparation. Triplicate syringes from each batch/kit (n = 15 per test group per day) were removed after 7 days, 14 days, 21 days, and 30 days of refrigerated storage. Samples were diluted to assay concentration (1 mg/mL) in ion-free water and filtered using a 0.22-micron microcentrifuge filter tube. Samples were analyzed for omeprazole recovery using a validated high-performance liquid chromatography with ultraviolet detection (HPLC-UV) method. Recovery was quantitatively assessed by comparing sample peak area to a freshly prepared calibration curve (1 – 0.125 mg/mL) using United States Pharmacopoeia (USP) reference standard on each day of sampling. Refrigerator temperatures were recorded daily using a digital thermometer.
Results:Stability was defined as recovery of 90 - 110% of initial concentration of API. For the FIRST® - Omeprazole samples, the chemical potency remained within this window for the entire study period of 30 days. The compounded omeprazole suspension demonstrated a less than 90% average recovery at the day 21 sample. Furthermore, a statistically significant difference in the initial concentration was detected on the day of compounding (p = 0.0244), with the compounded omeprazole starting at 1.89 ± 0.10 mg/mL and the FIRST® - Omeprazole at 1.98 ± 0.04 mg/mL. After 30 days, the compounded omeprazole suspension had an 89.13% average API recovery (standard deviation; ± 5.17%) and the FIRST® - Omeprazole 97.20% API recovery (± 3.59%).
Conclusion:Both traditionally compounded omeprazole suspension (2mg/mL) and FIRST® - Omeprazole suspension (2mg/mL) may be stored in clear luer-lock oral syringes under refrigeration for 14 days, and retain potency between 90 to 110% based on initial concentration. Furthermore, the FIRST® - Omeprazole suspension can be stored for the duration of the product’s beyond-use date of 30 days and retain potency between 90 to 110% of initial concentration or label claim. Finally, the data suggest that API concentration in FIRST® - Omeprazole suspension is more consistent from batch to batch than traditionally compounded omeprazole suspension.
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Sheth, Poonam. "Theoretical and Experimental Behavior of Suspension Pressurized Metered Dose Inhalers." Diss., The University of Arizona, 2014. http://hdl.handle.net/10150/325231.
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Pressurized metered dose inhalers (pMDIs) are widely utilized to manage diseases of the lungs, such as asthma and chronic obstructive pulmonary disease. They can be formulated such that the drug and/or nonvolatile excipients are dissolved or dispersed in the formulation, rendering a solution or suspension formulation, respectively. While the formulation process for solution pMDIs is well defined, the formulation process of pMDIs with any type of suspended entity can be lengthy and empirical. The use of suspended drug or the addition of a second drug or excipient in a suspension pMDI formulation may non-linearly impact the product performance of the drug of interest in the formulation; this requires iterative testing of a series of pMDIs in order to identify a formulation with the most potential for success. One of the primary attributes used to characterize the product performance and quality control of inhaled medications is the residual aerodynamic particle size distribution (APSD) of the aerosolized drug. Along with clinical factors, formulation and device parameters have a significant impact on APSD. In this study, a computational model was developed using the principles of statistics and physical chemistry to predict the residual APSD generated by suspension pMDIs based on formulation, device, and raw drug or excipient substance considerations. The formulations modeled and experimentally evaluated consist of a suspended drug or excipient with/without a dissolved drug or excipient in a cosolvent-propellant system. The in silico model enables modeling a process that is difficult to delineate experimentally and contributes to understanding the link between pMDI formulation and device to product performance. The ability to identify and understand the variables that affect atomization and/or aerosol disposition , such as initial droplet size, suspended micronized drug or excipient size, and drug or excipient concentration, facilitates defining the design space for suspension pMDIs during development and improves recognizing the sensitive of the APSD is on each hardware and formulation variable. This model can later be applied to limit batch-to-batch variation in the manufacturing process and selecting plausible suspension pMDI formulations with quality design as the end goal.
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Brown, Stacy D., Justin D. Connor, Nicholas C. Smallwood, and Ralph A. Lugo. "Quantification of Lansoprazole in Oral Suspension by Ultra-High-Performance Liquid Chromatography Hybrid Ion-Trap Time-of-Flight Mass Spectrometry." Digital Commons @ East Tennessee State University, 2011. https://dc.etsu.edu/etsu-works/5308.
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An LC-MS/MS method was developed and validated to be used as a stability indicating assay for the study of a 3 mg/mL lansoprazole oral suspension. The method utilizes a UPLC (ultra-performance liquid chromatography) column and unique mass spectrometric detection (ion-trap time-of-flight (IT-TOF)) to achieve a sensitive (LOD 2 ng/mL), accurate, and reproducible quantification of lansoprazole. This method reports an intraday and interday coefficient of variation of 2.98 ± 2.17% ( for each concentration for each day) and 3.07 ± 0.89% ( for each concentration), respectively. Calibration curves (5–25 μg/mL) were found to be linear with an value ranging from 0.9972 to 0.9991 on 4 different days. Accuracy of the assay, expressed as % error, ranged from 0.30 to 5.22%. This method is useful for monitoring the stability of lansoprazole in oral suspension.
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Gu, Alice. "Development of a Cucurbituril Suspension-Based Dosage Formulation and its Ability to Taste Mask Paracetamol." Thesis, The University of Sydney, 2021. https://hdl.handle.net/2123/25943.
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Medication non-adherence as a result of aversion to the bitter taste of active pharmaceutical ingredients and/or an inability to swallow solid dosage forms presents a challenge to the optimal use of medicines. The aims of this study were to examine the interactions of cucurbit[n]urils (CB[n]; n = 6, 7, 8) with paracetamol, and CB[7] with common pharmaceutical excipients, to design an effective oral suspension dosage formulation with CB[n]s as a potential taste masking excipient, and to assess the ability of CB[7] to reduce the bitter taste of paracetamol in rats. 1H NMR spectrometry was used to investigate the ability of CB[6], CB[7], and CB[8] to form host‒guest complexes with paracetamol, and interactions between CB[7] and common pharmaceutical excipients. Cucurbit[7]uril was able to form host‒guest complexes with paracetamol, but there was no binding between paracetamol and CB[6] and CB[8] most likely due to the salt (NaCl) used to dissolve the macrocycles. The only excipient found to interact with CB[7] was sodium propionate. a pharmaceutical suspension formulation based on CB[6] was designed to create a uniform product that was syringeable, easy to suspend and resuspend, and did not cake upon standing. The most stable formulation contained: CB[6] (171 mg/mL), propylene glycol (10–20% w/v), xanthan gum (0.05–0.1% w/v), potassium sorbate (0.2% w/v), sodium metabisulfite (0.25–0.5% w/v), and the dosage formulation made to volume using carboxymethyl cellulose (low viscosity) 1%–1.5% w/v. From the taste masking experiments, it was found that CB[7] was not effective in reducing the bitter taste of paracetamol, as the rats had a significantly lower preference for samples containing CB[7] and paracetamol compared with samples containing paracetamol alone.
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Morrison, Jordan T., Ralph A. Lugo, Jim C. Thigpen, and Stacy D. Brown. "Stability of Extemporaneously Prepared Lansoprazole Suspension at Two Temperatures." Digital Commons @ East Tennessee State University, 2013. https://dc.etsu.edu/etsu-works/5315.
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OBJECTIVE The purpose of this study was to examine the stability of a generic lansoprazole product in a 3 mg/mL sodium bicarbonate suspension under room temperature and refrigerated conditions. METHODS Lansoprazole suspensions (3 mg/mL) were prepared in triplicate using an 8.4% sodium bicarbonate vehicle for each storage condition (room temperature and refrigerated). During 1 month, samples from each replicate were periodically removed and analyzed for lansoprazole concentration by liquid chromatography–tandem mass spectrometry (LC-MS/MS). Each sample was spiked with 10 mg/L omeprazole to serve as the internal standard. A positive electrospray LC-MS/MS method was validated over the calibration range of 5 to 25 mg/L using Food and Drug Administration Guidance. The identities of the analyte and internal standard in the samples were verified by monitoring the MS/MS transitions of m/z 370 to m/z 252 and m/z 346 to m/z 198 for lansoprazole and omeprazole, respectively. Additionally, the pH of the suspensions was monitored throughout the study. RESULTS The stability of lansoprazole in the oral sodium bicarbonate suspension under refrigeration is compromised prior to what has been previously reported in the literature. Samples kept at room temperature lost >10% of the lansoprazole after 48 hours compared with the refrigerated samples, which maintained integrity up to 7 days. No statistically significant difference was found between the pH of the room temperature and refrigerated suspension samples, indicating that this factor is not the cause for the differences in stability at these two conditions. CONCLUSIONS This study suggests that the extemporaneously compounded lansoprazole oral suspension prepared in 8.4% sodium bicarbonate should not be stored in plastic oral syringes longer than 48 hours at room temperature and no longer than 7 days when refrigerated. These data indicate an expiration time earlier than that previously reported for the refrigerated product (14 days).
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Kaneko, Telma Mary. "Influência de agentes suspensores e edulcorantes na suspensão de estearato de eritromicina." Universidade de São Paulo, 1985. http://www.teses.usp.br/teses/disponiveis/9/9139/tde-11072011-112744/.
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As suspensões de estearato de eritromicina, de procedência nacional, apresentam a inconveniência que reside na elevada viscosidade ou flutuação do fármaco disperso. Foram estudados diferentes adjuvantes farmacotécnicos, a fim de verificar fatores interferentes que poderiam melhorar a estabilidade da suspensão de estearato de eritromicina. Como agentes suspensores foram utilizados BoniasolR2600 (carboximetilcelulose sódica), veegumR HV (silicato de alumínio e magnésio) e ViscosolR RV (glicolato de amido sódico) e como edulcorantes a glicerina, sorbitol a 70% e sacarose. As determinações analíticas para avaliar a estabilidade das suspensões foram: pH, densidade, viscosidade, aspecto da suspensão, volume do fármaco disperso, características de ressuspensão e doseamento do antibiótico. As suspensões contendo BoniasolR 260 e glicerina ou sorbitol não apresentaram o fenômeno da flutuação. As preparações contendo VeegumRRV e glicerina ou sorbitol na concentração de 30% (p/v) apresentaram estabilidade adequada.Suspensions of erithromycin stearate of national origin present the inconvenience of the high viscosity or of the flotation of the dispersed drug. Different pharmaceutical helpers were studied in order to verify of the erythromycin stearate suspension. BoniasolR2600 (sodium carboxymethyl cellulose), VeegumR HV (aluminum magnesium silicate) and ViscosolR RV (sodium starch glycollate) were used as suspending agents and glycerin, sorbitol at 70% and sucrose were used as sweeteners. Analytic determination to evaluate the suspensions stability were: pH, density, viscosity, aspecto of suspension, volume of the dispersed drug, resuspension characteristics and determination of the antibiotic dose. Suspensions containing BoniasolR 2600 and glycerin or sorbitol didn\'t present floatation. Preparation with veegumR HV and glycerin or sorbitol in a concentration of 30% (p/v) presented adequate stability.
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Iyer, Kavita A. "EXPLORING THE CONCEPT OF HUMAN OCT3 INHIBITORS AS A NOVEL CLASS OF ANTIDEPRESSANTS." VCU Scholars Compass, 2016. http://scholarscompass.vcu.edu/etd/4607.
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The Dukat laboratory developed 2-amino-6-chloro-3,4-dihydroquinazoline (A6CDQ) as a 5-HT3 receptor ligand. A6CDQ and one of its positional isomers, the 7-chloro analog A7CDQ, produced antidepressant-like effects in the mouse tail suspension test (TST). We investigated and systematically ruled out a solely 5-HT3 receptor or hSERT mediated mechanism of antidepressant-like effect for both A6CDQ and A7CDQ.
The role of organic cation transporter 3 (OCT3) as an alternative mechanism in the regulation of neurotransmitters including serotonin (5-HT) and the therapeutic potential of targeting hOCT3 to achieve antidepressant effects has been established. By virtue of possessing protonatable nitrogen atoms, 2-aminodihyroquinazolines could potentially exhibit activity at OCT3. A major goal of our present study was to explore the non-serotonergic mechanism of antidepressant-like effects and to study the as yet unexplored structure-activity-relationships (SARs) at OCT3. We examined the role of i) the chloro group, ii) the methylene bridge and iii) electronic/lipophilic effects at the 6-position.
We developed the first 3-D homology models of both the human and mouse orthologs of OCT3, conducted docking studies and HINT analysis, and identified critical amino acid residues interacting with 2-aminodihydroquinazoline analogs at hOCT3 and mOCT3. Retention of antidepressant-like activity in the mouse and potential locomotor stimulant effects for TST-active doses were thoroughly investigated.
We have successfully investigated initial SAR of 2-aminodihydroquinazolines at hOCT3 and generated the first 3-D homology models of hOCT3 and mOCT3. Highly potent and selective compounds could potentially be developed as radioligands to probe the binding site of OCT3 and as a mechanistically novel class of antidepressants.
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Zhao, Xiaoning. "Synthesis and applications of functional magnetic polymer beads; synthesis and mass spectrometry analysis of model peptides." Scholarly Commons, 2012. https://scholarlycommons.pacific.edu/uop_etds/156.
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The first part of the thesis describes the synthesis and application of functional magnetic polymer beads. The traditional suspension polymerization approach was used to synthesize polystyrene-iron oxide (Fe 3 O 4 ) based magnetic beads. The beads were coupled to different surface functional groups. The Fe 3 O 4 particles were encapsulated into a polystyrene shell. The surface functional groups were generated by graft-polymerization with functional monomers. The average size of the beads was in the range of 100-500 μm. Chemical tests showed that the beads were stable in strong acid, strong base and polar solvent. The beads had a fast response to an external magnetic field. A self-emulsion-polymerization approach was developed to synthesize smaller magnetic beads with the - OH groups on the surface. A modified approach based on traditional suspension-polymerization was developed to synthesize acid-durable beads with more Fe 3 O 4 encapsulated inside the beads. A novel emulsion-suspension polymerization method was successfully developed to synthesize much smaller magnetic beads ( A new peptide synthesis approach was developed using functional magnetic beads as the resin for solid phase synthesis. In this application, synthesized magnetic beads were further modified by a two-step reaction. The amino group was anchored onto the surface of these beads, followed by coupling with the Rink amide linker. The resulting beads were used as the resin to synthesize several model peptides. The peptides were successfully synthesized, and the sequences were confirmed by mass spectrometry analysis. The yields of the peptides were comparable to those obtained from commercial Rink amide resin. The second part of the thesis describes the synthesis and mass spectrometry analysis of two series of model peptides. One series has the linear (non-cyclic) structure, A n K, KA n , P n K, and AcA n K. The other series contains cyclic peptides, c-Ac-DAKAK and c-Ac-DADapAK. All peptides were synthesized using solid phase peptide synthesis. The relative proton affinities of the model peptides were measured using the collision induced dissociation experiments using a triple quadrupole mass spectrometer. It was found that the effective proton affinity of a cyclic peptide was significantly reduced compared to a linear analogue. The reduced proton affinity implies an increased lipophilicity of the peptide.
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Parkins, David Anthony. "The electrophoretic mobility of non-aqueous dispersions." Thesis, University of Bath, 1986. https://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.375332.
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Pavlakis, Evangelos K. "Novel drug coatings of pharmaceutical suspensions to control drug release of ibuprofen." Thesis, University of Huddersfield, 2005. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.417301.
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Abanzukwe, T. C. "Interactions of β-blockers with cell suspensions." Thesis, Loughborough University, 1986. https://dspace.lboro.ac.uk/2134/33121.
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Wang, Yingzhe. "The Characterization of Dry Powder Magnesium Hydroxide Suspensions Using Sedimentation, Thermal Analysis and Other Techniques." University of Toledo Health Science Campus / OhioLINK, 2011. http://rave.ohiolink.edu/etdc/view?acc_num=mco1322075364.
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Brown, Stacy D., J. T. Connor, N. C. Smallwood, and Ralph A. Lugo. "Quantitative Determination of Lansoprazole for Stability Study in Oral Suspensions Using LCMS-IT-TOF." Digital Commons @ East Tennessee State University, 2010. https://dc.etsu.edu/etsu-works/5293.
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D'Silva, Joseph Baptist. "Stability of drugs in pharmaceuticals : kinetics and mechanisms of hydrolysis in liposomal suspensions and aqueous solutions /." Ann Arbor, Mich. : University Microfilms International, 1987. http://www.gbv.de/dms/bs/toc/01614533x.pdf.
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Correll, Eric Owen. "Design of a rapid, continuous, small-scale device for creating dry powders from concentrated suspensions containing active pharmaceutical ingredients." Thesis, Massachusetts Institute of Technology, 2010. http://hdl.handle.net/1721.1/68832.
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Thesis (S.B.)--Massachusetts Institute of Technology, Dept. of Mechanical Engineering, June 2011."February 2011." Cataloged from PDF version of thesis.
Includes bibliographical references (p. 14).
Current methods of producing pharmaceutical compounds are large batch processes. The minimum time-to-patient for drug manufacturing is approximately 100 days. Using a continuous manufacturing process, the time-to-patient could be reduced to less than ten days. The scope of this paper encompasses the design of a machine for the desiccation of a mixture of solvent and pharmaceutical compound. The goal of this project was to provide a small-scale, high throughput method of continuous pharmaceutical drug drying for Novartis-MIT Center for Continuous Manufacturing. Specifications included a product flow rate of 100 grams per hour and a final product form of flowable powder. Several machines were built and tested, with the final design being comprised of a convective drum dryer and a modular continuous vacuum dryer.
by Eric Owen Correll.
S.B.
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Parisi, Ann Margaret. "Investigation of Secondary Metabolite Production in Selected Australian Native Species via Plant Cell Suspension Culture." Thesis, Griffith University, 2006. http://hdl.handle.net/10072/366129.
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Natural products and natural-product-derived substances comprised about
35% of the total pharmaceuticals market volume of US$230 billion in 1996
(Wessjohann, 2000). The success of natural-based drugs can be attributed to
nature’s ability to induce effects by chemical means and many of these chemicals
are able to pass species boundaries to cause an effect. Since plant secondary
metabolites have evolved in the interaction with other organisms, many of them
have interesting biological or therapeutical activities that are useful to man. In
addition to their intriguing chemistry a number of these compounds are
economically important, serving as pharmaceuticals, aromatics, fragrances,
stimulants, colours and pesticides.
Plant cell culture is viewed as a potential means of producing useful plant
products without the inherent problems associated with conventional agriculture.
Undifferentiated cell suspension cultures have the potential to produce varied
secondary metabolites by the alteration of culture conditions or addition of
chemicals to elicit expression of different metabolic pathways. Suitable substrate
compounds may be biotransformed to a desired product using plant cell cultures.
Biotransformation can produce compounds that can then be replicated by
synthetic means or produce novel compounds that have previously not been
identified or recognised as important. This thesis describes the initiation of plant
suspension cultures for the purposes of examining the production of secondary
metabolites of selected Australian native rainforest species.Thesis (PhD Doctorate)
Doctor of Philosophy (PhD)
School of Biomolecular and Biomedical Science
Science, Environment, Engineering and Technology
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Punnamaraju, Sri Ramya. "The Evaluation of the Sedimentation Behavior of Magnesium Hydroxide in the Never Dried State." University of Toledo Health Science Campus / OhioLINK, 2012. http://rave.ohiolink.edu/etdc/view?acc_num=mco1352945106.
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Consiglieri, Vladi Olga. "Avaliação da qualidade biofarmacêutica da ampicilina sob as formas de suspensão e cápsulas: ensaios in vitro e in vivo (bioequivalência)." Universidade de São Paulo, 1996. http://www.teses.usp.br/teses/disponiveis/9/9139/tde-24062008-084601/.
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A avaliação biofarmacêutica de formas farmacêuticas contendo ampicilina foi realizada em dois lotes de cápsulas e dois de suspensão oral. O estudo da bioequivalência seguiu delineamento experimental cruzado, com dois períodos, empregando 16 voluntários de ambos os sexos (7 homens e 9 mulheres), com idades entre 21 e 26 anos (média de 23 anos) e peso entre 48 e 105 Kg (média de 68,2 Kg), dentro do intervalo de 10 % do peso ideal. Exames clínicos e laboratoriais foram realizados para selecionar os voluntários, sendo excluídos aqueles que apresentaram alguma alteração nos parâmetros clínicos normais ou com histório de reação alérgica às penicilinas e, ainda, os indivíduos que estivessem fazendo uso de medicamentos a menos de uma semana da realização do estudo. O protocolo experimental foi aprovado previamente pela Comissão de Ética do Hospital Universitário (HUUSP). Os ensaios de bioequivalência foram efetuados em períodos distintos para cada forma farmacêutica, com uma semana de intervalo. No dia dos testes e após jejum de 12 horas, os voluntários foram divididos em dois grupos com igual número de indivíduos, sendo que, a cada grupo foi administrada dose única de 500 mg de ampicilina de lotes diferentes. Após período de wash out de 48 horas, a administração dos produtos aos grupos foi invertida para que todos os indivíduos recebessem ambos os produtos. A determinação quantitativa da ampicilina foi realizada em amostras de urina coletadas num período de doze horas, aplicando o método espectrofotométrico, com leituras a 320 nrn, após reação a 70° C em solução tampão fosfato/sulfato de cobre por 30 minutos. Os parâmetros farmacocinéticos calculados foram: quantidade acumulada de ampicilina na urina (Xuacumul), velocidade máxima de excreção urinária (Vmáx), tempo no qual essa velocidade foi atingida (tmáx), constantes de velocidade de eliminação (K) e de excreção urinária (ku)e a meia-vida de eliminação (t1/2). A recuperação de ampicilina inalterada na urina variou de 54,5 a 58,9 % e de 54,6 a 57,8 % das doses administradas para cápsulas e suspensão, respectivamente; a meia-vida média calculada foi de 1,9 h para cápsulas e de 1,7 h para suspensão. Os intervalos de confiança (α= 0,10) calculados para a razão das médias das quantidades acumuladas de ampicilina estão contidos no limite de 80 a120 %. A análise estatística dos resultados aplicando métodos paramétrico (ANOVA) e não paramétrico (Mann-Whitney), conforme as normas preconizadas pelo FDA, comprovou que não há diferenças significativas (nível de significância de 90 %) entre os produtos A e B quanto aos parâmetros estudados.A biopharmaceutic quality evaluation of two brands of ampicillin capsule and suspension dosage forms is presented. The bioequivalence study was based on an open randomized two-period crossover design with 7 male and 9 female healthy volunteers, aged 21 to 26 years (mean 23 yr) with body weights ranging from 48 to 105 Kg (mean 68,2 Kg) and within 10 % of the ideal body weight. All subjects passed by routine clinical and laboratory examinations. The volunteers had no histories of alergic reaction to penicillins and no other drugs were taken for at least 1 week before starting the study. The clinical protocol was approved by the Ethics Committee ofthe University Hospital (HUUSP). Studies were conducted separately for each dosage form after 1 week interval. On the day of the study, following an overnight fast, subjects were divided into two groups, each receiving 500 mg single dose of one of the two ampicillin dosage form. After a 2-day washout period, the same products were given in inversed order. Ampicillin data were obtained from urine samples collected over a 12 hour period. A spectrophotometric measurement at 320 nm after reaction in copper-phosphate/sulfate buffer solution at 70°C for 30 minutes was used. Total cummulative urinary excretion (Xuacumul), urinary excretion rates (Vmax), time to peak (tmax), urinary excretion rate constants (ku), elimination rate constants (K), and elimination half lives (t1/22) were calculated. Mean urine unchanged ampicillin recoveries of administered doses ranged from 54,5 to 58,9 % for capsules and from 54,6 to 57,8% for suspensions; t1/2 ranged from 1,7 to 1,9 h. Confidence intervals (α=0,10) for average rates were within 80-120 %. Statistic parametric (ANOVA) analysis and non-parametric analysis (Mann-Whitney) showed non-significance differences on the studied parameters of the two products at 90% significance leveI, according to FDA regulations.
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Chalamuri, Shanmuka Harish. "The Evaluation of the Effect of Anionic and Cationic Surfactants on the Hindered Settling of Light Calcium Carbonate Suspensions." University of Toledo Health Science Campus / OhioLINK, 2014. http://rave.ohiolink.edu/etdc/view?acc_num=mco1418602604.
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Azimi, Mandana. "EVALUATION OF THE REGIONAL DRUG DEPOSITION OF NASAL DELIVERY DEVICES USING IN VITRO REALISTIC NASAL MODELS." VCU Scholars Compass, 2017. http://scholarscompass.vcu.edu/etd/4780.
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The overall objectives of this research project were i) to develop and evaluate methods of characterizing nasal spray products using realistic nasal airway models as more clinically relevant in vitro tools and ii) to develop and evaluate a novel high-efficiency antibiotic nanoparticle dry powder formulation and delivery device. Two physically realistic nasal airway models were used to assess the effects of patient-use experimental conditions, nasal airway geometry and formulation / device properties on the delivery efficiency of nasal spray products. There was a large variability in drug delivery to the middle passages ranging from 17 – 57 % and 47 – 77 % with respect to patient use conditions for the two nasal airway geometries. The patient use variables of nasal spray position, head angle and nasal inhalation timing with respect to spray actuation were found to be significant in determining nasal valve penetration and middle passage deposition of Nasonex®. The developed test methods were able to reproducibly generate similar nasal deposition profiles for nasal spray products with similar plume and droplet characteristics. Differences in spray plume geometry (smaller plume diameter resulted in higher middle passage drug delivery) were observed to have more influence on regional nasal drug deposition than changes to droplet size for mometasone furoate formulations in the realistic airway models.
Ciprofloxacin nanoparticles with a mean (SD) volume diameter of 120 (10) nm suitable for penetration through mucus and biofilm layers were prepared using sonocrystallization technique. These ciprofloxacin nanoparticles were then spray dried in a PVP K30 matrix to form nanocomposite particles with a mean (SD) volume diameter of 5.6 (0.1) µm. High efficiency targeted delivery of the nanocomposite nasal powder formulation was achieved using a modified low flow VCU DPI in combination with a novel breathing maneuver; delivering 73 % of the delivered dose to the middle passages. A modified version of the nasal airway model accommodating Transwell® inserts and a Calu-3 monolayer was developed to allow realistic deposition and evaluation of the nasal powder. The nanocomposite formulation was observed to demonstrate improved dissolution and transepithelial transport (flux = 725 ng/h/cm2) compared to unprocessed ciprofloxacin powder (flux = 321 ng/h/cm2).
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Chan, Angel Thanda. "Nanoparticle engineering of colloidal suspension behavior /." 2007. http://gateway.proquest.com/openurl?url_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:dissertation&res_dat=xri:pqdiss&rft_dat=xri:pqdiss:3301261.
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Thesis (Ph. D.)--University of Illinois at Urbana-Champaign, 2007.Source: Dissertation Abstracts International, Volume: 69-02, Section: B, page: 1255. Adviser: Jennifer A. Lewis. Includes bibliographical references (leaves 117-122). Available on microfilm from Pro Quest Information and Learning.
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Monteiro, Sofia da Silva Santos Rebocho. "Air Stripping Process for Organic Solvent Removal Pharmaceutical Process Unit Development." Master's thesis, 2018. http://hdl.handle.net/10362/38338.
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Oncological protein-drug complex is being developed in TEVA, Haarlem, as well as the encompassing manufacture process engineering buildup. Due to poor solubility of the studied active pharmaceutical ingredient, organic solvent is used during compounding stage and needs to be sub sequentially removed. Its long removal duration impacts key process parameters such as nano-suspension stability and formation of undesired crystals.
The overall purpose of this study was to determine the feasibility of implementing an air stripping process unit in the existing line of production which would be a breakthrough in the current process by accelerating the solvent removal. The column was tested in pilot plant scale in order to collect and analyze experimental data to determine column’s operational parameters and hydrodynamic properties as well as its efficiency and overall process time reduction by air stripping unit introduction.
Presence of protein and nano-particles was proved to have delaying effect on solvent mass transfer rate due to increased interface resistance and diffusional limitation due to nano-suspension heterogeneous model. The introduction of the column experimentally showed significant improvement in terms of overall evaporation reduction time; from 30 to about 5 hours, depending on the operating parameters and the set-up. The column was additionally designed to fit the model and could reach a theoretical value of 2 hours of stripping for a 500L solution at a maximum of 4 L/min and 30°C to avoid foam and protein denaturation respectively. The air stripping process did not de-stabilize the nano-suspension, showing constant particle size and polydispersity index.
The optimistic collected results validate the advantages of air stripping column implementation in the complex drug manufacture and suggest future work and research with column can be sustained.
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(9080312), Andrew J. Radcliffe. "DEVELOPMENT OF DROPWISE ADDITIVE MANUFACTURING WITH NON-BROWNIAN SUSPENSIONS: APPLICATIONS OF COMPUTER VISION AND BAYESIAN MODELING TO PROCESS DESIGN, MONITORING AND CONTROL." Thesis, 2020.
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In the past two decades, the pharmaceutical industry has been engaged in modernization of its drug development and manufacturing strategies, spurred onward by changing market pressures, regulatory encouragement, and technological advancement. Concomitant with these changes has been a shift toward new modalities of manufacturing in support of patient-centric medicine and on-demand production. To achieve these objectives requires manufacturing platforms which are both flexible and scalable, hence the interest in development of small-scale, continuous processes for synthesis, purification and drug product production. Traditionally, the downstream steps begin with a crystalline drug powder – the effluent of the final purification steps – and convert this to tablets or capsules through a series of batch unit operations reliant on powder processing. As an alternative, additive manufacturing technologies provide the means to circumvent difficulties associated with dry powder rheology, while being inherently capable of flexible production.
Through the combination of physical knowledge, experimental work, and data-driven methods, a framework was developed for ink formulation and process operation in drop-on-demand manufacturing with non-Brownian suspensions. Motivated by the challenges at hand, application of novel computational image analysis techniques yielded insight into the effects of non-Brownian particles and fluid properties on rheology. Furthermore, the extraction of modal and statistical information provided insight into the stochastic events which appear to play a notable role in drop formation from such suspensions. These computer vision algorithms can readily be applied by other researchers interested in the physics of drop coalescence and breakup in order to further modeling efforts.
Returning to the realm of process development to deal with challenges of monitoring and quality control initiated by suspension-based manufacturing, these machine vision algorithms were combined with Bayesian modeling to enact a probabilistic control strategy at the level of each dosage unit by utilizing the real-time image data acquired by an online process image sensor. Drawing upon a large historical database which spanned a wide range of conditions, a hierarchical modeling approach was used to incorporate the various sources of uncertainty inherent to the manufacturing process and monitoring technology, therefore providing more reliable predictions for future data at in-sample and out-of-sample conditions.
This thesis thus contributes advances in three closely linked areas: additive manufacturing of solid oral drug products, computer vision methods for event recognition in drop formation, and Bayesian hierarchical modeling to predict the probability that each dosage unit produced is within specifications.