Relevant bibliographies by topics / Pharmaceutical excipient

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  1. Journal articles
  2. Dissertations / Theses
  3. Books
  4. Book chapters
  5. Conference papers

Academic literature on the topic 'Pharmaceutical excipient'

Author: Grafiati
Published: 14 July 2021
Last updated: 17 February 2022

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Journal articles on the topic "Pharmaceutical excipient"

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Bin, Liew Kai, Anand Gaurav, and Uttam Kumar Mandal. "A REVIEW ON CO-PROCESSED EXCIPIENTS: CURRENT AND FUTURE TREND OF EXCIPIENT TECHNOLOGY." International Journal of Pharmacy and Pharmaceutical Sciences 11, no. 1 (January 1, 2019): 1. http://dx.doi.org/10.22159/ijpps.2019v11i1.29265.

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There is no single-component excipient fulfills all the requisite performance to allow an active pharmaceutical ingredient to be formulated into a specific dosage form. Co-processed excipient has received much more attention in the formulation development of various dosage forms, specially for tablet preparation by direct compression method. The objective of this review is to discuss the emergence of co-processed excipients as a current and future trend of excipient technology in pharmaceutical manufacturing. Co-processing is a novel concept of combining two or more excipients that possess specific advantages that cannot be achieved using a physical admixture of the same combination of excipients. This review article discusses the advantages of co-processing, the need of co-processed excipient, general steps in developing co-processed excipient, limitation of co-processed excipient, technologies used in developing co-processing excipients, co-processed excipients in the literature, marketed products and future trends. With advantages offered by the upcoming newer combination of excipients and newer methods of co-processing, co-processed excipients are for sure going to gain attraction both from academia and pharmaceutical industry. Furthermore, it opens the opportunity for development and use of single multifunctional excipient rather than multiple excipients in the formulation.
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Patel, Rahul, James Barker, and Amr ElShaer. "Pharmaceutical Excipients and Drug Metabolism: A Mini-Review." International Journal of Molecular Sciences 21, no. 21 (November 3, 2020): 8224. http://dx.doi.org/10.3390/ijms21218224.

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Conclusions from previously reported articles have revealed that many commonly used pharmaceutical excipients, known to be pharmacologically inert, show effects on drug transporters and/or metabolic enzymes. Thus, the pharmacokinetics (absorption, distribution, metabolism and elimination) of active pharmaceutical ingredients are possibly altered because of their transport and metabolism modulation from the incorporated excipients. The aim of this review is to present studies on the interaction of various commonly-used excipients on pre-systemic metabolism by CYP450 enzymes. Excipients such as surfactants, polymers, fatty acids and solvents are discussed. Based on all the reported outcomes, the most potent inhibitors were found to be surfactants and the least effective were organic solvents. However, there are many factors that can influence the inhibition of CYP450, for instance type of excipient, concentration of excipient, type of CYP450 isoenzyme, incubation condition, etc. Such evidence will be very useful in dosage form design, so that the right formulation can be designed to maximize drug bioavailability, especially for poorly bioavailable drugs.
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Tita, Ioana Cristina, Lavinia Lupa, Bogdan Tita, Roxana Liana Stan, and Laura Vicas. "Compatibility Studies of Valsartan with Different Pharmaceutical Excipients." Revista de Chimie 70, no. 7 (August 15, 2019): 2590–600. http://dx.doi.org/10.37358/rc.19.7.7386.

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Compatibility studies between active drugs and excipients are substantial in the pharmaceutical technology. Thermal analysis has been extensively used to obtain information about drug-excipient interactions and to perform pre-formulation studies of pharmaceutical dosage forms. The objective of the present study was to evaluate the compatibility of the valsartan (VALS) with pharmaceutical excipients of common use including diluents, binders, disintegrants, lubricants and solubilising agents. Thermogravimetry (TG), derivative thermogravimetry (DTG), but especially differential scanning calorimetry (DSC) were used for a first screening to find small variations in peak temperature and/or their associated enthalpy for six drug/excipient mixtures (starch, cross caramelose sodique, microcrystalline cellulose 102, povidone K30, lactose monohydrate and magnesium stearate), which indicate some degree of interaction. Additional methods using Fourier transformed infrared spectroscopy (FT-IR) and X-ray powder diffraction (XRPD) confirmed the incompatibility of VALS with starch, povidone K30, lactose monohydrate and magnesium stearate. Those excipients should be avoided in the development of solid dosage forms.
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Santos, Ana, Francisco Veiga, and Ana Figueiras. "Dendrimers as Pharmaceutical Excipients: Synthesis, Properties, Toxicity and Biomedical Applications." Materials 13, no. 1 (December 21, 2019): 65. http://dx.doi.org/10.3390/ma13010065.

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The European Medicines Agency (EMA) and the Current Good Manufacturing Practices (cGMP) in the United States of America, define excipient as the constituents of the pharmaceutical form other than the active ingredient, i.e., any component that is intended to furnish pharmacological activity. Although dendrimers do not have a pharmacopoeia monograph and, therefore, cannot be recognized as a pharmaceutical excipient, these nanostructures have received enormous attention from researchers. Due to their unique properties, like the nanoscale uniform size, a high degree of branching, polyvalency, aqueous solubility, internal cavities, and biocompatibility, dendrimers are ideal as active excipients, enhancing the solubility of poorly water-soluble drugs. The fact that the dendrimer’s properties are controllable during their synthesis render them promising agents for drug-delivery applications in several pharmaceutical formulations. Additionally, dendrimers can be used for reducing the drug toxicity and for the enhancement of the drug efficacy. This review aims to discuss the properties that turn dendrimers into pharmaceutical excipients and their potential applications in the pharmaceutical and biomedical fields.
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Sopyan, Iyan, and Rizka Guntina Khairunisa. "Mini Review : Sedem System as a Tool to Characterize Excipients in Solid Dosage Form." Indonesian Journal of Pharmaceutics 3, no. 1 (March 20, 2021): 20. http://dx.doi.org/10.24198/idjp.v3i1.34038.

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SeDem System is a new system that can be applied in solid dosage form preformulation studies of medicines. It have parameters to evaluates critical quality attributes of materials that have an impact on final drug product’s quality. SeDeM studies could be used as a method for identifying the best excipient and calculating the maximum amount of excipient required for formulation. SeDeM method can , providing formulation with the lowest amount of excipients as it combines the Active Pharmaceutical Ingredients (API) with only one excipient and the standard formula of lubricants, thus avoiding the used of unnecessary excipients, such as diluents, binders and agglutinants. The information given by the SeDeM system contributes to a quality by drug design development.Keywords: SeDeM System, Excipients
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Patel, Jalpa, and Dhaval Mori. "Application of 32 Full Factorial Design and Desirability Function for Optimizing The Manufacturing Process for Directly Compressible Multi-Functional Co-Processed Excipient." Current Drug Delivery 17, no. 6 (August 6, 2020): 523–39. http://dx.doi.org/10.2174/1567201817666200508094743.

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Background: Developing a new excipient and obtaining its market approval is an expensive, time-consuming and complex process. Compared to that, the co-processing of already approved excipients has emerged as a more attractive option for bringing better characteristic excipients to the market. The application of the Design of Experiments (DoE) approach for developing co-processed excipient can make the entire process cost-effective and rapid. Objective: The aim of the present investigation was to demonstrate the applicability of the DoE approach, especially 32 full factorial design, to develop a multi-functional co-processed excipient for the direct compression of model drug - cefixime trihydrate using spray drying technique. Methods: The preliminary studies proved the significant effect of atomization pressure (X1) and polymer ratio (microcrystalline cellulose: mannitol - X2) on critical product characteristics, so they were selected as independent variables. The angle of repose, Carr’s index, Hausner’s ratio, tensile strength and Kuno’s constant were selected as response variables. Result: The statistical analysis proved a significant effect of both independent variables on all response variables with a significant p-value < 0.05. The desirability function available in Design Expert 11® software was used to prepare and select the optimized batch. The prepared co-processed excipient had better compressibility than individual excipients and their physical mixture and was able to accommodate more than 40 percent drug without compromising the flow property and compressibility. Conclusion: The present investigation successfully proved the applicability of 32 full factorial design as an effective tool for optimizing the spray drying process to prepare a multi-functional co-processed excipient.
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Viera-Herrera, Camila, Javier Santamaría-Aguirre, Karla Vizuete, Alexis Debut, Daniel C. Whitehead, and Frank Alexis. "Microcrystalline Cellulose Extracted from Native Plants as an Excipient for Solid Dosage Formulations in Drug Delivery." Nanomaterials 10, no. 5 (May 19, 2020): 975. http://dx.doi.org/10.3390/nano10050975.

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Excipients represent the complement of the active principle in any pharmaceutical form. Their function is to provide stability, protection, and to ensure absorption of the drug and acceptability in patients. Cellulose is a conventional excipient in many pharmaceutical solid dosage products. Most of the sources used to extract microcrystalline cellulose come from cotton or wood, which are expensive and in high demand from other industries. As plants are considered the main source of excipient production, we have taken advantage of the biodiversity of Ecuador to evaluate microcrystalline cellulose extracted from borojó (Alibertia patinoi), a native plant, as an excipient for solid dosage formulations. The method of choice for tablet manufacturing was direct compression since it is a conventional fabrication method in the pharmaceutical industry. First, we performed scanning electron microscopy (SEM), Fourier-transform infrared (FTIR) spectroscopy, and X-ray diffraction (XRD) in order to compare the structure and characteristics of the extracted cellulose with two reference commercial cellulose materials. Second, we performed quality tests to evaluate the use of the isolate as an excipient including fluidity, hardness, friability, and disintegration. Compared with commercial and microcrystalline cellulose, the extracted cellulose from the native plant showed comparable characteristics and is consequently a potential excipient that could be used in the pharmaceutical industry. Last, we performed a dissolution test in which we concluded that all tablets have a short release time of active principle.
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Pituanan, Baginda Sati, and Silvia Surini. "FAST-DISINTEGRATING TABLET FORMULATION OF GINGER (ZINGIBER OFFICINALE ROSC.) EXTRACT USING COPROCESSED EXCIPIENT OF PRE-GELATINIZED CASSAVA STARCH-ACACIA GUM." International Journal of Applied Pharmaceutics 9 (October 30, 2017): 154. http://dx.doi.org/10.22159/ijap.2017.v9s1.77_84.

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Objective: Fast-disintegrating tablets (FDTs) are tablets that disintegrate and/or dissolve rapidly in the mouth, thereby helping patients who havedifficulty in swallowing tablets. Ginger extract contains gingerol and is generally known for its antiemetic property. This study aimed to obtain anduse coprocessed excipients of pre-gelatinized cassava starch (PCS) with acacia gum (AG) in FDT formulations of ginger extract.Materials and Methods: In this research, five types of PCS-AG coprocessed excipients (Co-PCS-AG) were prepared by mixed PCS and AG with thefollowing ratios mass of PCS and AG were 5:5, 6:4, 7:3, 8:2, and 9:1. The prepared Co-PCS-AG excipients were characterized in terms of morphology,particle size distribution, moisture content, pH, flow-ability properties, and swelling index. Based on the results, three types of Co-PCS-AG excipients,which were 7:3, 8:2, and 9:1, were selected for use in FDT formulation of ginger extract. The FDTs were then examined for tablet hardness, tabletfriability, wetting time, and disintegration time.Results: The results indicated that Co-PCS-AG 9:1 was ideal excipient to be used in FDT formulation, as it revealed good flow properties and swellingindex compare to the other ratios. The Co-PCS-AG excipients were formulated into tablets and evaluated. Analysis of the ginger extract FDTs revealedthat the FDT prepared using Co-PCS-AG 9:1 excipient had the best performance with tablet hardness, friability, wetting time, and disintegration timeof 0.7 kp, 2.12%, 93 seconds, and 134 seconds, respectively.Conclusions: Co-PCS-AG 9:1 excipient is a potential excipient with ideal binder, disintegrant, and filler properties for use in FDT formulation.
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Shanware, Sidhhi, Kamlesh Wadher, Jayashree Taksande, and Milind Umekar. "Lepidium sativum Linn: Applications and Pharmaceutical Excipient Properties." International Journal of ChemTech Research 13, no. 4 (2020): 374–82. http://dx.doi.org/10.20902/ijctr.2019.130406.

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Natural gums and mucilages are familiar for their medicinal and pharmaceutical excipient properties. Mucilages from plant sources are found to be very potential, interesting and valuable in development of desired pharmaceutical dosage forms. Lepidium sativum Linn (Family Cruciferae)is oe of the mucilage containing edible annual herb used to treat various human ailments.The plant possesses flavonoids, coumarins, sulphur glycosides, triterpenes, sterols and various imidazole alkaloids. Parts of plats such as leaves, fruits and seeds along with various extracts of them have different pharmaceutical activities. Lepidium sativum seeds contains large amounts of mucilaginous constituents when soaked in water and a transparent gel forms around the whole seed. It mainly consists of polysaccharides, especially cellulose and uronic acid. Recently mucilarge obtained from its seeds been explored for its excipient property in the development and design of various pharmaceutical dosage forms. This review mainly focuses on application and pharmaceutical excipients properties of mulicage of Lepidium sativum Linn.
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Iyan Sopyan, Ni Made Widya Sukma Santi, Alif Virisy Berlian, Noer Erin Meilina, Qisti Fauza, and Restu Amelia Apriyandi. "A review: Pharmaceutical excipients of solid dosage forms and characterizations." International Journal of Research in Pharmaceutical Sciences 11, no. 2 (April 3, 2020): 1472–80. http://dx.doi.org/10.26452/ijrps.v11i2.2020.

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Excipients play an important role in formulating dosage forms. Exertion is empowered to help manufacture, provide, or collect dosage forms. Although considered pharmacological, excipients may consider a drug, due to chemical or physical interactions with the composition of the drug. Excipients have many functions in pharmaceutical dosage forms, including enhancing active ingredients in dosage forms, assisting active ingredients, disintegration, lubricants, binders, and suppliers. Each excipient has different characteristics. In this review, a library of studios is provided relating to the function, function, and content of solid excipients in a solid sedan. Various choices can be used on different compositions; resulting, this difference is also different. In this example, describe the types of excipients that can be used for various components in solid preparations that can be used in the formulation of solid preparations and select the right type of excipient according to the character of the desired solid preparation. In this review also presented a method, combining in and characterizing solid excipients to see the quality. The most commonly used methods for analysis of solid excipients are flow properties, compressibility index, Hausner index ratios, and angle of repose, while the instrumentation commonly used is Fourier transform infrared spectroscopy (FTIR), H and C-Nucleo magnetic resonance (H-CNMR), Scanning electron microscopy (SEM), Particle size analysis (PSA), X-ray diffraction (XRDP) and Differential scanning calorimeter (DSC).
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Dissertations / Theses on the topic "Pharmaceutical excipient"

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Nep, E. I. "Grewia polysaccharide gum as a pharmaceutical excipient." Thesis, Aston University, 2010. http://publications.aston.ac.uk/10310/.

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Grewia gum is obtained from the inner stem bark of the edible plant Grewia mollis Juss (Fam. Tiliaceae) which grows widely in the middle belt region of Nigeria, and is also cultivated. The dried and pulverised inner stem bark is used as a thickening agent in some food delicacies in that region of the country. This ability of the material to increase solution viscosity has generated a lot of interest and is the catalysing momentum for this research. Such materials have been used as stabilizers or suspending agents in cosmetics, foods and liquid medications, and as mucoadhesives and controlled release polymeric matrices in solid dosage forms. The physicochemical characterization of candidate excipients forms an essential step towards establishing suitability for pharmaceutical application. For natural gums, this usually requires isolation of the gum from the storage site by extraction processes. Grewia polysaccharide gum was extracted and dried using techniques such as air-drying, freeze-drying or spray-drying. Component analysis of the gum showed that it contains five neutral sugars: glucose, galactose, rhamnose, arabinose and xylose. The gum contains traces of elements such as zinc, magnesium, calcium and phosphorus. At low substance weight, the gum hydrates in aqueous medium swelling and dispersing to give a highly viscous dispersion with pseudoplasmic flow behaviour. The method by which drying is achieved can have significant effect on some physicochemical properties of the gum. Consequently, the intrinsic viscosity and molecular weight, and parameters of powder flow were shown to differ with the method of drying. The gum has good thermal stability. In comparison with established excipients, grewia gum may be preferable to gum Arabic or sodium carboxymethylcellulose as a suspending agent in ibuprofen suspension formulations. The release retardant property of the gum was superior to guar and Metolose® in ibuprofen matrices. Similarly, carboxy methylcellulose, Methocel®, gum Arabic or Metolose® may not be preferable to grewia gum when controlled release of a soluble drug like cimetidine is indicated. The mucoadhesive performance of the gum compared favourably with excellent mucoadhesives such as hydroxypropyl methylcellulose, carboxymethylcellulose, guar and carbopol 971 P.
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Mackin, L. A. "The effects of moisture on triboelectrification of selected pharmaceutical excipient powders." Thesis, University of Sunderland, 1995. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.245985.

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The literature contains conflicting reports on the effect of moisture on triboelectrification, indeed experiments have shown moisture to increase, decrease or have no effect at all on the charging of solids. The research programme investigated the role of moisture in the triboelectrification of a range of pharmaceutical excipients. Selection of excipients was made on the basis of a) moisture sorption capacity (the starch group) and b) potential use in dry powder inhaler formulations (the sugar and sorbitol group). The following excipients were selected for preliminary investigations:- a-lactose monohydrate, dextrose monohydrate, sorbitol spray dried (SSD), sorbitol powder, sucrose, maize and potato starch and Primojel™.
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Camargo, Jhon Jairo Rojas. "Assessment of co-processing of cellulose II and silicon dioxide as a platform to enhance excipient functionality." Diss., University of Iowa, 2011. https://ir.uiowa.edu/etd/2763.

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This thesis project studied microcrystalline cellulose II (CII), a polymorphic form of cellulose, which has lower mechanical properties, less plastic deformation, higher elastic recovery and faster disintegration properties than microcrystalline cellulose I (CI). Also, the effects of processing and silicification on CII materials were investigated. Particle modification through spray drying, wet granulation and spheronization was employed to improve CII performance. Spray-drying (SDCII) and wet granulation (WGCII) produced materials with no difference in mechanical or disintegration properties from unprocessed CII, but did show an increase in density and particle flow. Conversely, spheronization (SPCII) showed the poorest mechanical properties compared to CII. Further, SDCII showed better dilution potential than CII. Thus the advantages of SDCII were apparent when it was mixed with a poorly compressible drug (acetaminophen) because fibrous CII was converted to spheroidal particles through spray drying. The rapid disintegration of SDCII and CII compacts was due to water wicking through capillaries followed by compact bursting. Compacts of ibuprofen mixed with SDCII and Avicel® PH-102 had comparable disintegration rates and release profiles compared to ibuprofen formulated with commercial disintegrants and Avicel® PH-102, especially at levels 10% w/w. Adding fumed silica into CII particles through spray drying, wet granulation (WGCII) and spheronization (SPCII) at 2-20% w/w was also studied. Silicification increased physical properties such as true density, Hausner ratio, porosity, ejection force and specific surface area of SDCII and WGCII. Other properties such as bulk and tap densities were reduced due to the amorphous and light character of fumed silica. Spheronized CII showed no change in these properties with silicification. Silicification diminished lubricant sensitivity with magnesium stearate due to the competition of SiO2 with magnesium stearate to coat CII particles. Silicification also decreased the affinity of CII for water only at the 20% w/w level due to the few silanol groups available for water interaction compared to surface hydroxyl groups on CII alone. Particle size modification of CII was process-dependent rather than silicification-dependent. Additionally, silicification decreased the apparent plasticity and elastic recovery of SDCII and WGCII when compacted. The former effect along with increased powder porosity increased surface area and compressibility of SDCII and WGCII. Compact tensile strength of silicified CII materials was in the order: spray-dried > wet granulated > spheronized. This order was due to the combined effect of particle morphology and how fumed silica was incorporated and distributed within CII particles. Silicification did not affect the rapid disintegration properties of CII. Thus, diphenhydramine HCl and griseofulvin tablets prepared with silicified CII had faster disintegration and release than those prepared with commercial silicified CI (Prosolv®). Moreover, CII beads containing diphenhydramine HCl or griseofulvin had faster release profiles compared to beads prepared with Prosolv® SMCC 50 or Avicel® PH-101. This behavior showed that rapid disintegration is an intrinsic property of CII. Compact tensile strength decreased more for unsilicified CI and CII compacts stored at 75% RH, while silicified CI and CII compacts lost less tensile strength under the same conditions. Reprocessed CI materials containing acetaminophen (1:1mixtures) lost 35-72% of their original strength compared to silicified CII materials (15-25% loss) indicating more particle interaction upon recompression. .
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Tant, Martin Ray. "Biopharmaceutic and Pharmacokinetic Studies of Sucrose Acetate Isobutyrate as an Excipient for Oral Drug Delivery." Digital Commons @ East Tennessee State University, 2011. https://dc.etsu.edu/etd/1345.

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Sucrose acetate isobutyrate (SAIB), a randomly substituted sucrose approximating sucrose diacetate hexaisobutyrate, is produced by Eastman Chemical Company for a variety of applications. SAIB is widely used in the food industry as a weighting agent to disperse flavoring oils in primarily citrus-based soft drink beverages. Additionally, SAIB is currently being marketed by another company as a parenteral drug delivery system. The studies reported here focused on investigating SAIB as an excipient, or delivery vehicle, for use in oral delivery of several drugs, including ibuprofen, saquinavir, and clarithromycin. Dissolution experiments were conducted using both ibuprofen and caffeine, and results suggest that SAIB can be used in dosage forms to control release rate. Pharmacokinetic studies in which laboratory rats were dosed with formulations containing drugs such as ibuprofen, saquinavir, and clarithromycin suggest that SAIB may act to reduce animal-to-animal variability in drug concentration profiles in some cases, and that it may also enhance gastroretention of the dosage forms. Finally, dosage form imaging studies suggest but do not reliably confirm that SAIB may aid in promoting gastric retention, which would make its use in dosage form formulation beneficial for administration of drugs whose action is intended to occur in the stomach.
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Tinmanee, Radaduen. "The role of pharmaceutical excipients in the solid-state degradation of Gabapentin." Diss., University of Iowa, 2015. https://ir.uiowa.edu/etd/1919.

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Drug instability in solid dosage forms includes chemical or physical processes involving covalent or polymorphic transformations wherein different polymorphs possess crystal structure differences. Gabapentin chemically degrades by intramolecular cyclization to gabapentin-lactam (lactam) in the solid-state. Additionally, gabapentin undergoes polymorphic solid-state transformations. A kinetic model was developed to describe the environmental and excipient effects on chemical and physical instability associated with milling induced stress and subsequent storage under controlled temperature and humidity conditions. Reaction mixtures were generated by co-milling gabapentin Form II with various excipients. The effects of environmental conditions were studied by storing reaction mixtures at 40-60 ºC and 5-50 %RH. The chemical and polymorphic compositions of the reaction mixtures were measured as a function of time using a combination of chromatographic method, 13C ssNMR and XRPD. Degradation models that describe the relationship between polymorphs and degradation product in a series of sequential or parallel steps were devised based on analysis of the resultant concentration time profiles. Model parameters were estimated using non-linear regression and Bayesian methods and evaluated in terms of their quantitative relationship to compositional and conditional variations. In reaction mixtures composed of co-milled gabapentin and excipients, gabapentin was found to exist in three forms: anhydrous polymorph II and III and gabapentin-lactam. A fourth form (II*) was observed based on initial degradation kinetics and was hypothesized to be a crystal-disordered form generated by mechanical stress. The effect of environment moisture was to decrease the net rate of lactam formation by facilitating polymorphic transformation kinetics and crystal annealing. However, excipient blocked the catalytic moisture effect on polymorphic transformations. The key features of our model are first-order physical state transitions of II* and III to II, first-order degradation of II* to lactam and autocatalytic lactamization of II and III. For chemical transitions, no humidity effect was present but the catalytic effects of excipients on the conversion of II and III → lactam were observed. For physical transitions, excipient primarily influenced the physical state transitions of II*and III → II through its ability to interact with humidity and the degree of contact between excipient and substrate.
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Gupta, Patel Salin. "MECHANISMS AND THERMODYNAMICS OF THE INFLUENCE OF SOLUTION-STATE INTERACTIONS BETWEEN HPMC AND SURFACTANTS ON MIXED ADSORPTION ONTO MODEL NANOPARTICLES." UKnowledge, 2019. https://uknowledge.uky.edu/pharmacy_etds/103.

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Nanoparticulate drug delivery systems (NDDS) such as nanocrystals, nanosuspensions, solid-lipid nanoparticles often formulated for the bioavailability enhancement of poorly soluble drug candidates are stabilized by a mixture of excipients including surfactants and polymers. Most literature studies have focused on the interaction of excipients with the NDDS surfaces while ignoring the interaction of excipients in solution and the extent to which the solution-state interactions influence the affinity and capacity of adsorption. Mechanisms by which excipients stabilize NDDS and how this information can be utilized by formulators a priori to make a rational selection of excipients is not known. The goals of this dissertation work were (a) to determine the energetics of interactions between HPMC and model surfactants and the extent to which these solution-state interactions modulate the adsorption of these excipients onto solid surfaces, (b) to determine and characterize the structures of various aggregate species formed by the interaction between hydroxypropyl methylcellulose (HPMC) and model surfactants (nonionic and ionic) in solution-state, and (c) to extend these quantitative relationships to interpret probable mechanisms of mixed adsorption of excipients onto the model NDDS surface. A unique approach utilizing fluorescence, solution calorimetry and adsorption isotherms was applied to tease apart the effect of solution state interactions of polymer and surfactant on the extent of simultaneous adsorption of the two excipients on a model surface. The onset of aggregation and changes in aggregate structures were quantified by a fluorescence probe approach with successive addition of surfactant. In the presence of HPMC, the structures of the aggregates formed were much smaller with an aggregation number (Nagg) of 34 as compared to micelles (Nagg ~ 68) formed in the absence of HPMC. The strength of polymer-surfactant interactions was determined to be a function of ionic strength and hydrophobicity of surfactant. The nature of these structures was characterized using their solubilization power for a hydrophobic probe molecule. This was determined to be approximately 35% higher in the polymer-surfactant aggregates as compared to micelles alone and was attributed to a significant increase in the number of aggregates formed and the increased hydrophobic microenvironment within these aggregates at a given concentration of surfactant. The energetics of the adsorption of SDS, HPMC, and SDS-HPMC aggregate onto nanosuspensions of silica, which is the model solid surface were quantified. A strong adsorption enthalpy of 1.25 kJ/mol was determined for SDS adsorption onto silica in the presence of HPMC as compared to the negligible adsorption enthalpy of 0.1 kJ/mol for SDS alone on the silica surface. The solution depletion and HPMC/ELSD methods showed a marked increase in the adsorption of SDS onto silica in the presence of HPMC. However, at high SDS concentrations, a significant decrease in the adsorbed amount of HPMC onto silica was determined. This was further corroborated by the adsorption enthalpy that showed that the silica-HPMC-SDS aggregation process became less endothermic upon addition of SDS. This suggested that the decrease in adsorption of HPMC onto silica at high SDS concentrations was due to competitive adsorption of SDS-HPMC aggregates wherein SDS is displaced/desorbed from silica in the presence of HPMC. At low SDS concentrations, an increase in adsorption of SDS was due to cooperative adsorption wherein SDS is preferentially adsorbed onto silica in the presence of HPMC. This adsorption behavior confirmed the hypothesis that the solution-state interactions between pharmaceutical excipients such as polymers and surfactants would significantly impact the affinity and capacity of adsorption of these excipients on NDDS surfaces.
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El, Sanadi Caroline Elizabeth. "THE VALUE OF A FUNCTIONAL EXCIPIENT ADDITIVE TO HUMAN INSULIN THERAPIES: FROM MANUFACTURE TO HUMAN CLINICAL TRIAL." Case Western Reserve University School of Graduate Studies / OhioLINK, 2015. http://rave.ohiolink.edu/etdc/view?acc_num=case1450286879.

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Elgaied-Lamouchi, Dhouha. "Découverte de nouveaux excipients pharmaceutiques à base d'amidons modifiés pour une libération prolongée d'une substance active." Thesis, Lille, 2020. https://pepite-depot.univ-lille.fr/.

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Les comprimés matriciels hydrophiles sont fréquemment utilisés pour contrôler la libération d’actif dans les formes galéniques à usage oral. Les amidons représentent un choix intéressant pour cette application. En effet, ce sont des matériaux biocompatibles, biodégradables et disponibles à partir de différentes sources végétales. En plus des amidons natifs, les amidons modifiés (AM) ont été beaucoup étudiés pour la formulation des comprimés matriciels à libération prolongée. Les modifications physico-chimiques peuvent être ajustées de manière à correspondre aux propriétés souhaitées pour une application pharmaceutique spécifique. De nombreux scientifiques ont rapportés l'utilisation de ces amidons pour les comprimés à libération contrôlée. Ils ont obtenu des résultats prometteurs montrant la capacité de ces excipients à retarder la libération d’actif dans. Cependant, la plupart des amidons utilisés dans ces études sont généralement produits à l'échelle laboratoire, et peuvent donc présenter des propriétés différentes des AM produits à l’échelle industrielle. Par conséquent, il pourrait être très difficile de transposer la production de ces amidons à l’échelle industrielle sans altérer leurs propriétés caractéristiques. L'objectif principal de ce travail était d'identifier un nouvel excipient à base d'amidon pour contrôler la libération d’actif à partir de comprimés. Ainsi, dans un premier temps, un grand criblage a permis d'étudier différents types d'amidons pour préparer des comprimés de diprohylline par compression directe. L'impact de l'origine botanique des amidons, de la méthode de pré-gélatinisation, du degré et de la nature de réticulation, ainsi que la substitution chimique ont été étudiées et les cinétiques de libération d’actif ont été mesurées. Pour avoir une meilleure compréhension de ces résultats, l’analyse de texture de l’hydrogel formé au contact du milieu de libération, la microscopie optique et électronique à balayage (MEB) ainsi que l’analyse par diffraction des rayons X ont été réalisées. De plus, un « test rapide » a été mis en place pour évaluer le potentiel d'un d'amidon donné à prolonger libération d’actif. Les résultats obtenus sur l'importance du type d'amidon et leur impact sur les cinétiques de libération d’actif des comprimés matriciels peuvent aider à mieux assimiler et optimiser ces systèmes avancés d'administration de médicaments. Dans une deuxième partie, le potentiel du (PREGEFLO® PI10) a été évalué comme agent matriciel pour les comprimés à libération prolongée. Pour ce faire, différents types de comprimés chargés d’actifs ayant une solubilité différente ont été préparés par compression directe. La robustesse de cette matrice a été étudiée dans des milieux de libération très variés. Plusieurs appareils de dissolution ont été utilisés séparément ou combinés avec d'autres machines pour simuler le stress hydrodynamique subi par les comprimés lors de leur passage à travers le tractus gastro-intestinal. Les résultats obtenus ont montré que les profils de libération d’actif à partir du PREGEFLO® PI10 n'étaient pas affectés par toutes les conditions étudiées. Ainsi, le PREGEFLO® PI10 se positionne comme un bon candidat comme polymère de libération prolongée pour la voie orale. Enfin, pour caractériser la distribution d’actif au sein du système matriciel, en particulier dans les régions «sèches» et gonflés après dissolution du comprimé, et examiner comment les distributions spatiales changent au cours du temps, l'imagerie Raman, la MEB, la spectroscopie de rayons X à dispersion d'énergie (EDX) et la cristallographie aux rayons X ont été utilisées sur des comprimés avant et après exposition au tampon. Les cartographies Raman ont confirmé que l’actif est bien piégé dans le noyau du comprimé «sec». Ces observations ont mis en évidence la différence de morphologie entre la région centrale « sèche » et la région dans laquelle la matrice du comprimé a subi un gonflement important
Hydrophilic matrix tablets are frequently used to control the drug release from oral dosage forms. Starch-based polymers are interesting matrix former in this respect, due to their biocompatibility, biodegradability, and availability from different plant sources. In addition to native starches, modified starches have been frequently used with various physiochemical modifications, which could be tailored to provide desired properties for a specific pharmaceutical application. Many scientists have reported the use of modified starches as matrix formers for oral controlled release tablets. Numerous starch-based extended release polymers have successfully retarded drug releases. However, most of the starch batches used in those studies are generally produced at a laboratory scale and may therefore present different properties compared to modified starches obtained with industrial scale. Hence, it could be very difficult to scale up the production of these excipients without changing their key features. The major goal of this work was to identify a new excipient, based on starch to control the drug release from direct compressible matrix tablets. Therefore, in a first instance, a large screening allowed to study different types of starches to prepare diprophylline matrix tablets. The effect of the botanical origin of starches, the type of pre-gelatinization method as well as of the degree and type of cross-linking and chemical substitution have been investigated, and the resulting drug release rates from diprophylline-loaded matrix tablets were measured. For a better understanding of these results, texture analysis of the gel-layer, created upon contact with the release medium, optical and scanning electron microscopy (SEM) as well as X- ray powder diffraction analysis were applied. Moreover, a “quick test” has been proposed to evaluate the potential of a particular type of starch to sustain the drug release rate. The obtained results on the importance of the starch type and their influence on the resulting drug release rates from matrix tablets can help for a better understanding and optimization of this type of advanced drug delivery systems. In a second phase, the potential of (PREGEFLO® PI10), has been evaluated as a matrix former for controlled release tablets. Hence, various types of matrix tablets loaded with drugs having different solubility were prepared by direct compression. The robustness of this cross-linked pregelatinized potato starch matrix was investigated in a variety of release media. In addition to that, several types of experimental USP apparatuses were used separately or combined with other devices to simulate the mechanical stress the tablets are exposed to during transpassage of the gastrointestinal tract. The obtained results showed that the drug release rates from PREGEFLO® PI10 matrix were not impacted by all the conditions studied. Therefore, the explored starch excipient offers an interesting potential as matrix former in controlled release tablets. Finally, to characterize the drug distribution throughout the matrix system, in particular in the “dry” and swollen tablet regions after hydration and the way the spatial distribution patterns change with time, the tablets were investigated using Raman imaging, SEM and Energy Dispersive X-ray Spectroscopy (EDX) before and after exposure to phosphate buffer. The Raman images confirmed that the drug is effectively trapped within the “dry” tablet core. The internal structure of the vacuum-dried tablets was visualized using SEM analysis. These observations highlighted the difference in the morphology between the “dry” core region and the region in which the tablet matrix underwent substantial swelling. The polysaccharide formed a continuous hydrogel in which the drug dissolved. SEM and EDX images have rendered visible the interface “dry “core-swollen gel and the spatial distribution of the drug in both regions. The diprophylline content is predictably much highe
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Velásquez, Armijo Cristián Jesús. "Aplicação de métodos termo-analíticos e espectroscóspicos na avaliação do comportamento do fármaco isoniazida frente a adjuvantes tecnológicos." reponame:Biblioteca Digital de Teses e Dissertações da UFRGS, 2003. http://hdl.handle.net/10183/144233.

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Os métodos termo-analíticos são ferramentas úteis na avaliação da compatibilidade entre fármacos e adjuvantes, com destaque à calorimetria exploratória diferencial. Neste trabalho foram avaliados a compatibilidade e o comportamento térmico entre a isoniazida e adjuvantes tecnológicos primários usualmente empregados em formas farmacêuticas sólidas. A compatibilidade foi examinada por meio da preparação de misturas físicas binárias do tipo fármaco/adjuvante. Foi investigada também a influência da granulação por via úmida e do processo de compactação para as misturas de isoniazida e adjuvantes com função de material de enchimento e carga e deslizante. A isoniazida apresentou um comportamento térmico não encontrado na literatura. Os adjuvantes avaliados foram: ácido esteárico, amido, celulose microcristalina, crospovidona, croscarmelose sódica, dióxido de silício coloidal estearato de magnésio, glicolato de amido sódico, hipromelose, lactose, manitol, polidona e talco. Para as misturas físicas, a maioria dos adjuvantes mostrou-se compatível com o fármaco em questão. Foram verificadas interações com o ácido esteárico, o glicolato de amido sódico, a lactose, o manitol e a povidona. A isoniazida mostrou a formação de uma mistura eutética com o manitol e de interação química com a lactose. A agregação por via úmida e o processo de compactação não mostraram influências adicionais na compatibilidade das misturas avaliadas. Os resultados observados foram confirmados por métodos não-térmicos como difratometria de raios X, espectroscopia de infravermelho e ressonância nuclear magnética.
Thermo-analytical methods, and specially Differential Scanning Calorimetry, are useful support for the evaluation of compatibility between drug substances and pharmaceutical excipients. In this work were studied the compatibility and the thermal behavior of isoniazid and pharmaceutical excipients, commonly used for the formulation of solid dosage forms. Colloidal silicon dioxide, corn starch, crospovidone, hypromellose, lactose, magnesium stearate, mannitol, microcrystalline cellulose, povidone, sodium croscarmellose, sodium starch glycolate, stearic acid and talc were the excipients employed in these experiments. The compatibility was analyzed testing binary physical drug/excipient admixtures. The effect of wet granulation and compression was also investigated, in this case especially between isoniazid, fillers and lubricant. For almost all excipients no incompatibilities with isoniazid were observed. Interactions were detected when the drug substance was added to stearic acid, sodium starch glycolate, lactose, mannitol and povidone. Isoniazid formed a euthetic mixture with mannitol, whereas a possible chemical reaction occurred between isoniazid and lactose. Wet granulation and compaction of the tested admixtures did not affect the results observed above. These observations were confirmed by non-thermal techniques, such as X-Ray diffractometry, infrared spectroscopy and nuclear magnetic resonance.
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Mansa, Rola. "Preparation and Characterization of Novel Montmorillonite Nanocomposites." Thèse, Université d'Ottawa / University of Ottawa, 2011. http://hdl.handle.net/10393/20207.

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Clay minerals have historically played a consequential role in human health. While the beginnings were rooted in geophagy, a primitive act of consuming earth, the health-related uses of clay minerals have evolved and diversified over time. As excipients in pharmaceutical formulations, clay minerals can attribute novel properties onto intercalated compounds. Intercalating oxybenzone, a UV filter, within the interlamellar space of montmorillonite is desirable in order to minimize direct contact with skin. Intercalating resveratrol, a compound known for attributing beneficial effects onto human health, may be advantageous since this compound is susceptible to cis-trans isomerisation. The strategy of using alkylammonium–modified clay was undertaken and proved successful for the intercalation of oxybenzone. The field of biopolymer/layered silicate nanocomposites is heavily researched for use in a multitude of applications. Novel montmorillonite nanocomposites were prepared with neutral guar gum and cationic guar gum, using an environmentally friendly process and are fully characterized.
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Books on the topic "Pharmaceutical excipient"

1

Koo, Otilia M. Y., ed. Pharmaceutical Excipients. Hoboken, NJ, USA: John Wiley & Sons, Inc., 2016. http://dx.doi.org/10.1002/9781118992432.

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Formulate '94 Symposium (1994 Manchester, England). Excipients and delivery systems for pharmaceutical formulations. Cambridge: The Royal Society of Chemistry, 1995.

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Bugay, David E. Pharmaceutical excipients: Characterization by IR, Raman, and NMR spectroscopy. New York: M. Dekker, 1999.

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Rowe, Raymond C. Handbook of pharmaceutical excipients: Edited by Raymond C. Rowe, Paul J. Sheskey, Marian E. Quinn. 6th ed. London: APhA/Pharmaceutical Press, 2009.

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Brittain, H. G. Profiles of drug substances, excipients and related methodology. Oxford: Academic, 2010.

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Brittain, H. G. Profiles of drug substances, excipients, and related methodology. Amsterdam: Elsevier Academic Press, 2009.

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J, Sheskey Paul, Cook Walter G, Fenton Marian E, and American Pharmacists Association, eds. Handbook of pharmaceutical excipients: Edited by Raymond C. Rowe, BPharm, PhD, DSC, FRPharmS, FRSC, CPhys, MlnstP, chief scientist, Paul J. Sheskey, BSc, RPh, principal research scientist, the Dow Chemical Company, Midland, MI, USA, Walter G. Cook, BSc, PhD, research fellow, Materials Science group of Pharmaceutical R&D, Pfizer, Sandwich, Kent, UK, Marian E. Fenton, BSc, MSc, development editor, Royal Pharmaceutical Society of Great Britain, London, UK. London: APhA/Pharmaceutical Press, 2012.

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Survey of active pharmaceutical ingredients-excipient incompatibility. LAP LAMBERT Academic Publishing AG & Co. KG, Dudweiler Landstr. 99, 66123 Saarbrücken, Germany, 2010.

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Survey of active pharmaceutical ingredients-excipient incompatibility. LAP LAMBERT Academic Publishing AG & Co. KG, Dudweiler Landstr. 99, 66123 Saarbrücken, Germany, 2010.

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Weiner/KotKosKi. Excipient Toxicity and Safety (Drugs and the Pharmaceutical Sciences). Informa Healthcare, 1999.

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Book chapters on the topic "Pharmaceutical excipient"

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Good, David, and Yongmei Wu. "Excipient Characterization." In Pharmaceutical Excipients, 1–49. Hoboken, NJ, USA: John Wiley & Sons, Inc., 2016. http://dx.doi.org/10.1002/9781118992432.ch1.

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Nahler, Gerhard. "excipient." In Dictionary of Pharmaceutical Medicine, 69–70. Vienna: Springer Vienna, 2009. http://dx.doi.org/10.1007/978-3-211-89836-9_522.

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Moreton, R. C. "Excipient Standards and Harmonization." In Pharmaceutical Excipients, 199–240. Hoboken, NJ, USA: John Wiley & Sons, Inc., 2016. http://dx.doi.org/10.1002/9781118992432.ch5.

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Vashisth, Priya, Harmeet Singh, Parul A. Pruthi, and Vikas Pruthi. "Gellan as Novel Pharmaceutical Excipient." In Handbook of Polymers for Pharmaceutical Technologies, 1–21. Hoboken, NJ, USA: John Wiley & Sons, Inc., 2015. http://dx.doi.org/10.1002/9781119041375.ch1.

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Silverstein, Irwin. "Pharmaceutical Excipient Good Manufacturing Practices." In Good Manufacturing Practices for Pharmaceuticals, 227–40. Seventh edition. | Boca Raton, Florida : CRC Press, 2019.: CRC Press, 2019. http://dx.doi.org/10.1201/9781315120669-16.

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Lee, Carlos. "Addressing Drug–Excipient Interactions." In Sample Preparation of Pharmaceutical Dosage Forms, 131–43. Boston, MA: Springer US, 2011. http://dx.doi.org/10.1007/978-1-4419-9631-2_6.

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Desai, Parind M., Lai Wah Chan, and Paul Wan Sia Heng. "Drug Substance and Excipient Characterization." In Handbook of Pharmaceutical Granulation Technology, 69–102. 4th ed. Fourth edition. | Boca Raton, FL : CRC Press, 2021. | Series: Drugs and the pharmaceutical sciences: CRC Press, 2021. http://dx.doi.org/10.1201/9780429320057-3-4.

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Schalau, Gerald K., and Hyder A. Aliyar. "Silicone Excipients in Pharmaceutical Drug Delivery Applications." In Excipient Applications in Formulation Design and Drug Delivery, 423–62. Cham: Springer International Publishing, 2015. http://dx.doi.org/10.1007/978-3-319-20206-8_14.

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Gogos, Costas G. "Excipient or API Melt Processing via Injection Molding." In AAPS Advances in the Pharmaceutical Sciences Series, 261–79. New York, NY: Springer New York, 2013. http://dx.doi.org/10.1007/978-1-4614-8432-5_11.

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Boddu, Sai HS, Jwala Renukuntla, Alan Rega, and Kenneth Alexander. "Excipients and Non-medicinal Agents as Active Pharmaceutical Ingredients." In Excipient Applications in Formulation Design and Drug Delivery, 613–36. Cham: Springer International Publishing, 2015. http://dx.doi.org/10.1007/978-3-319-20206-8_21.

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Conference papers on the topic "Pharmaceutical excipient"

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Benkő, Ernő Máté, Tamás Sovány, and Ildikó Csóka. "API – excipient interactions in non-biodegradable solid matrix systems." In I. Symposium of Young Researchers on Pharmaceutical Technology,Biotechnology and Regulatory Science. Szeged: Institute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, Faculty of Pharmacy, 2019. http://dx.doi.org/10.14232/syrptbrs.2019.op9.

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Benkő, Ernő Máté, Tamás Sovány, and Ildikó Csóka. "API – excipient interactions in non-biodegradable solid matrix systems." In II. Symposium of Young Researchers on Pharmaceutical Technology,Biotechnology and Regulatory Science. Szeged: Institute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, Faculty of Pharmacy, 2020. http://dx.doi.org/10.14232/syrptbrs.2020.op28.

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Löbmann, Korbinian. "Amorphous stabilisation using proteins as excipients." In The 1st International Electronic Conference on Pharmaceutics. Basel, Switzerland: MDPI, 2020. http://dx.doi.org/10.3390/iecp2020-08783.

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Basit, Abdul, Yang Mai, Diane Ashiru-Oredope, Zhicheng Yao, Christine Madla, Liu Dou, Farhan Taherali, and Sudaxshina Murdan. "Boosting drug bioavailability in men but not women through the action of an excipient." In The 1st International Electronic Conference on Pharmaceutics. Basel, Switzerland: MDPI, 2020. http://dx.doi.org/10.3390/iecp2020-08629.

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Suciu, Stefana, Sonia Iurian, Rita Ambrus, Cătălina Bogdan, and Ioan Tomuță. "Milk oral lyophilisates with loratadine: screening for new excipients for paediatric use." In III. Symposium of Young Researchers on Pharmaceutical Technology,Biotechnology and Regulatory Science. Szeged: Institute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, Faculty of Pharmacy, 2021. http://dx.doi.org/10.14232/syrptbrs.2021.op41.

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Kemp, Regina, Kevin Fraser, Kyoko Fujita, Douglas MacFarlane, and Gloria Elliott. "Biocompatible Ionic Liquids: A New Approach for Stabilizing Proteins in Liquid Formulation." In ASME 2008 Summer Bioengineering Conference. American Society of Mechanical Engineers, 2008. http://dx.doi.org/10.1115/sbc2008-192986.

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The stabilization of proteins is a priority for several important fields, most notably the pharmaceutical industry. Protein-based therapeutic drugs have demonstrated significant efficacy in controlling and curing disease. Unlike traditional small molecule-based drug therapies, a major hurdle in the development of protein drugs is the challenge of maintaining the protein in the folded state throughout processing and also during storage at the end point-of-use. When a protein is taken from its native environment, it is often unstable and unfolds. Because the protein’s 3-dimensional structure is responsible for its functional activity, much work has been dedicated to finding excipients that will stabilize proteins outside of their native environment.
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Busignies, Virginie, Pierre Evesque, Patrice Porion, Bernard Leclerc, Pierre Tchoreloff, Masami Nakagawa, and Stefan Luding. "Mechanical properties of compacts made with binary mixtures of pharmaceutical excipients of three different kinds." In POWDERS AND GRAINS 2009: PROCEEDINGS OF THE 6TH INTERNATIONAL CONFERENCE ON MICROMECHANICS OF GRANULAR MEDIA. AIP, 2009. http://dx.doi.org/10.1063/1.3179902.

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Albaraki, Saeed, S. Joseph Antony, and C. Babatunde Arowosola. "Visualising shear stress distribution inside flow geometries containing pharmaceutical powder excipients using photo stress analysis tomography and DEM simulations." In POWDERS AND GRAINS 2013: Proceedings of the 7th International Conference on Micromechanics of Granular Media. AIP, 2013. http://dx.doi.org/10.1063/1.4812029.

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