Classifications

• • C—CHEMISTRY; METALLURGY
  • C07—ORGANIC CHEMISTRY
  • C07H—SUGARS; DERIVATIVES THEREOF; NUCLEOSIDES; NUCLEOTIDES; NUCLEIC ACIDS
  • C07H23/00—Compounds containing boron, silicon or a metal, e.g. chelates or vitamin B12
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/0012—Galenical forms characterised by the site of application
  • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/08—Solutions
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K31/00—Medicinal preparations containing organic active ingredients
  • A61K31/33—Heterocyclic compounds
  • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
  • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
  • A61K31/409—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil having four such rings, e.g. porphine derivatives, bilirubin, biliverdine
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K33/00—Medicinal preparations containing inorganic active ingredients
  • A61K33/24—Heavy metals; Compounds thereof
  • A61K33/26—Iron; Compounds thereof
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
  • A61K47/02—Inorganic compounds
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
  • A61K9/00—Medicinal preparations characterised by special physical form
  • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P13/00—Drugs for disorders of the urinary system
  • A61P13/12—Drugs for disorders of the urinary system of the kidneys
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
  • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
  • A61P7/08—Plasma substitutes; Perfusion solutions; Dialytics or haemodialytics; Drugs for electrolytic or acid-base disorders, e.g. hypovolemic shock

Definitions

• the intravenous (IV) iron agents are colloids that consist of spheroidal iron- carbohydrate nanoparticles as shown in Fig. 1. At the core of each particle is an iron- oxyhydroxide gel and the core is surrounded by a shell of carbohydrate that stabilizes the iron- oxyhydroxide (the main function of the ligand is to stabilize the complex and to protect it against further polynuclearization).
• Iron carbohydrate complexes behave as prodrugs, since the iron has to be released from the iron(lll)-hydroxide core.
• the stable (Type 1) complexes such as ferric carboxymaltose and iron dextran are taken up by endocytosis by macrophages of the reticuloendothelial system (RES). See Danielson, J. Structure, chemistry, and pharmacokinetics of intravenous iron agents. Am. Soc. Nephrol. 2004, 15, S93-S98.
• INFeD ® / Dexferrum ® Iron dextran
• Ferahem ® Ferumoxytol
• Injectafer ® ferric carboxymaltose
• Venofer ® Iron sucrose
• Ferrlecit ® Sodium ferric gluconate complex
• Iron sucrose sold under the name Venofer ® , is formulated as a colloidal suspension having a molecular weight (M w ) of about 34,000-60,000 Daltons and a molecular formula as follows:
• n is the degree of iron polymerization and m is the number of sucrose molecules (C. sub.12 H. sub.22 O. sub.11) in complex with the poly-nuclear polymerized iron core:
• Each mL contains 20 mg elemental iron as iron sucrose in water for injection.
• Venofer ® is available in 5mL single dose vials (100 mg elemental iron per 5 mL) and 10 mL single dose vials (200 mg elemental iron per 10 mL).
• the drug product contains approximately 30% sucrose w/v (300 mg/mL) and has a pH of 10.5-11.1.
• the product contains no preservatives.
• the osmolarity of the injection is 1,250 mOsmol/L.
• the invention relates to aqueous iron sucrose compositions having desirable properties.
• the aqueous irons sucrose composition comprises iron sucrose and bicarbonate.
• the invention relates to an aqueous iron pharmaceutical composition comprising: iron sucrose; bicarbonate; and a pharmaceutically acceptable aqueous carrier.
• the invention relates to a method for prevention or treatment of a kidney disease or disorder comprising intravenously administering an aqueous iron composition in a therapeutically effective amount, wherein the aqueous iron composition comprises iron sucrose and bicarbonate.
• Fig. 1 shows the structure of an iron carbohydrate.
• Fig. 2 is a Western blot of kidney at 18 hours post administration of aqueous iron compositions.
• Fig. 3 shows GPC chromatograms of three SI preparations.
• Fig. 4 shows a zoom view of Fig. 3.
• Fig. 5 shows GPC chromatograms of three SI preparations.
• Fig. 6 shows a zoom view of Fig. 5.
• Fig. 7 shows GPC chromatograms of three SI preparations.
• Fig. 8 shows a zoom view of Fig. 7
• Fig. 9 shows a comparison of GPC for SI, S2, and S3.
• Fig. 10 shows an AFM top and side view for SI.
• Fig. 11 shows SI, particles size analysis at location 1.
• Fig. 12 shows SI, manual section analysis of three particles.
• Fig. 13 shows FTIR spectra of SI and the best library match, sucrose.
• Fig. 14 shows FTIR spectra of S2 and the best library match, sucrose.
• Fig. 15 shows FTIR spectra of S3 and the best library match, dextran.
• Fig. 16 shows 1H NMR spectra of Sl-preparation 1
• FIG. 17 shows 1H NMR spectra of S2-preparation 1
• FIG. 18 shows 1H NMR spectra of S3-preparation 1
• FIG. 19 shows 13C NMR spectra of Sl-preparation 1
• FIG. 20 shows 13C NMR spectra of S2-preparation 1
• FIG. 21 shows 13C NMR spectra of S3-preparation 1
• FIG. 22 shows Raw data comparison for the three samples (lyophilized)
• FIG. 23 shows Offset overlay of the data from all three samples (two replicates for S3)
• Fig. 24 shows TGA thermogram of SI, S2 and S3 under nitrogen purge condition.
• Fig. 25 shows DSC thermograms of SI, S2 and S3.
• the present invention involves an aqueous iron sucrose
• FeS-bicarb composition can be utilized as a renal protective agent.
• the FeS-bicarb composition according to embodiments of the invention is preferentially absorbed in the kidney compared to commercially available forms of FeS.
• FeS-bicarb results in preferential upregulation of kidney protective molecule(s) relative to FeS alone.
• the FeS-bicarb composition of the present invention may be advantageously combined with other renal protective agents such as tin protoporphyrin (SnPP) to readily form injectable renal protective agents.
• SnPP tin protoporphyrin
• FeS-bicarb One advantage of using the FeS-bicarb is that this composition results in elevated renal protective effects. Specifically, the inventors found that FeS-bicarb preferentially upregulated kidney protective molecules relative to FeS alone. While not wishing to be bound by theory, the present inventors have proposed that the bicarb in addition to FeS may alter the relative levels of Fe(lll) and Fe(ll) present. Because of the observed redness in the FeS-bicarb product, the inventors have proposed that the compositions of the invention may include elevated levels of Fe(ll). This could explain the elevated renal protective effects, given the higher reactivity of Fe(ll) relative to Fe(lll).
• One advantage of using the FeS-bicarb is that the bicarb has a buffering effect.
• the SnPP composition may be combined with the FeS-bicarb composition in a ratio of less than or equal to about 1:1 SnPP:FeS, such as about 1:2, about 1:4, about 1:8, about 1:10, about 1:20, about 1:50, about 1:100, about 1:1000, about 1:10,000, about 1:100,000, about 1:1,000,000, or any integer or subrange in between.
• the composition has a molecular weight measured using GPC as described in Example 1.
• the Mp is preferably within the range of between 25,000 and 35,000 Daltons, more preferably between 28,000 and 32,000 Daltons, and most preferably about 29,000 Daltons.
• the Mw is preferably within the range of between 25,000 and 45,000 Daltons, more preferably between 30,000 and 40,000 Daltons, even more preferably between 33,000 and 38,000 Daltons, and most preferably about 34,000 Daltons.
• the Mn is preferably within the range of between 15,000 and 30,000 Daltons, more preferably between 20,000 and 25,000 Daltons, and most preferably about 24,000 Daltons.
• the polydispersity (PDI) is preferably within the range of 1.35 to 1.60, more preferably within the range of 1.38 and 1.5, even more preferably within the range 1.40 and 1.48, and most preferably about 1.4.
• the composition has a stable zeta potential of -3.0 mV or less, more preferably -7.0 mV or less, and most preferably around -lOmV.
• the composition has a total organic carbon of less than 8.5%, preferably less than 8.0%, and most preferably about 7.7%.
• the osmolality as measured in accordance with Example 1 is within the range of 550 and 1600 mOsm/kg, preferably within the range of 1500 and 1580 mOsm/kg, and most preferably about 1540 mOsm/kg.
• the present invention involves a composition that is prepared by dissolving enough iron sucrose complex in water (ca 3.5L) to give a 12 mg/mL (expressed as iron) solution when diluted to 6.0 L.
• the amount of iron sucrose needed was calculated for the final volume of liquid, 6100 mL (6.1L) so that the final c.Ooncentration is 12 mg/mL. This requires 73.2 g of iron.
• the use potency of iron sucrose is 0.0550. Thus, 73.2 g / 0.0550 or 1331 g ⁇ 1 g of iron sucrose is needed.
• Iron sucrose, 1331 g ⁇ 1 g was weighed directly into a 6.0 L Erlenmeyer flask. Approximately 3-3.5 L of water is added to the Erlenmeyer flask, and the contents of the flask are stirred.
• bicarbonate concentration is lOmg/mL when diluted to 6.0L.
• Sodium bicarbonate, 109.8 ⁇ O.lg, is weighed and added to the 6.0 L flask.
• Sodium chloride is added in an amount such that the final sodium chloride concentration is 9.0 mg/mL upon dilution.
• Sodium chloride, 54.9 ⁇ 0.1, is weighed and added to the 6.0 L flask. The suspension is stirred for 30-120 minutes to give a black opaque solution.
• the solution is then transferred to a volumetrically accurate flask and diluted to 6.1L with water.
• a 2 L volumetric flask is used twice to transfer exactly 4L of the 10.3 pH solution to a 6L Erlenmeyer flask.
• the remaining 10.3 pH solution is diluted to 2 L in a volumetric flask and added to the 6L Erlenmeyer flask.
• the 100 mL graduated cylinder is used to add 100 ⁇ 0.1 mL to the 6.0 L Erlenmeyer, and the resulting solution is stirred for 10 minutes.
• the resulting material had a pH of 10.3, which is within the preferred limits of 10.1-10.4.
• the resultant material had 11.5 / 11.6 parts per thousand (mg/mL) iron according to SOP 174472, which determines iron through inductively coupled plasma-mass spectroscopy.
• Example 3 FeS-bicarb composition of Example 1 was filtered and placed in a vial and had a
• FeS (Venofer) or Fe+ SnPP.
• N normal control.
• Glyc is glycerol, used as a positive H chain ferritin control.
• N normal samples (controls). As is apparent, Fe induces an increase in heavy chain in kidney.
• EXAMPLE 5 A patient suffering from chronic kidney disease is treated by intravenous injection using the aqueous iron composition of iron sucrose and bicarbonate of Example 1.
• a patient undergoing organ transplantation is treated by intravenous injection using the aqueous iron composition of iron sucrose and bicarbonate of Example 1.
• a patient undergoing organ transplantation is treated by intravenous injection using the aqueous iron composition of iron sucrose and bicarbonate of Example 1, in combination with tin protoporphyrin.
• SI iron-sucrose
• S2 is the commercially available product
• Venofer ® iron sucrose injection
• S3 is the commercially available product INFeD ® (iron dextran injection). The results are summarized in Table 8 below.
• GPC is used to determine the molecular weight distribution of polymers.
• a solution of the polymer is passed through a column packed with a porous gel.
• the sample is separated based on molecular size with larger molecules eluting quicker than smaller molecules.
• the retention time of each component is detected and compared to a calibration curve, and the resulting data is then used to calculate the molecular weight distribution for the sample.
• a distribution of molecular weights rather than a unique molecular weight is characteristic of all types of synthetic polymers. To characterize this distribution, statistical averages are used. The most common of these averages are the “number average molecular weight” (Mn) and the “weight average molecular weight” (Mw).
• the number average molecular weight is similar to the standard arithmetic mean associated with a group of numbers. When applied to polymers, the number-average molecular weight refers to the average molecular weight of the molecules in the polymer. The number average molecular weight is figured giving the same amount of significance to each molecule regardless of its individual molecular weight. The number average molecular weight is figured by the following formula where Ni is the number of molecules with a molar mass equal to Mi.
• weight average molecular weight Mw.
• the weight average molecular weight is another statistical descriptor of the molecular weight distribution that provides more for significance of larger molecules than the smaller molecules in the distribution.
• the formula below shows the statistical calculation of the weight average molecular weight.
• weight average molecular weight There are two general reasons for the weight average molecular weight. First, if comparing, for example toughness, the longer molecules influence the toughness of the polymer distribution more so than the shorter molecules do. The weight average molecular weight calculation gives emphasis to these longer molecules, and provides a comparative number that can describe the relative contribution of the long molecules present in a molecular weight distribution. The weight average molecular weight is also a number that is directly correlated to the molecular weight determination of polymers by light scattering, small angle neutron scattering (SANS), and sedimentation velocity.
• SANS small angle neutron scattering
• the weight average molecular weight provides insight to the shape of a molecular weight distribution.
• This value in connection with the number average molecular weight, provides a ratio determination of the broadness of the molecular weight distribution referred to as the polydispersity index or PI.
• the PI is defined as the ratio of Mw/Mn. The larger the PI, the more disperse the distribution is. The lowest value that a PI can be is 1. This represents a monodispersed sample - a polymer with all of the molecules in the distribution being the same molecular weight.
• Mz z-average molecular weight
• the peak molecular weight value is defined as the mode of the molecular weight distribution. It signifies the molecular weight that is most abundant in the distribution. This value also gives insight to the molecular weight distribution.
• GPC Precisions and bias are based on statistical data such as an average of measurements, standard deviation, relative percent difference, and/or percent relative standard deviation.
• the amounts listed in the tables above were referenced to a known amount of standard and are quantitative. Calibration curves were prepared, and relative standard deviation and relative percent difference information are referenced in the report above.
• For semi-quantitative typical reproducibility as determined by statistical process control of the measurement system is estimated at about 10% (at 95% confidence level, k ⁇ 2). This reproducibility is an estimate of the uncertainty of a single standard measurement over time, and the uncertainty in a specific measurement must be determined on a case by case basis.
• analytical reference standards were not analyzed to confirm the presence of the individual components.
• samples SI and S2 contained two peaks with unique molecular weight distributions while sample SB contained three peaks. Also note that a Mp could not be calculated for "Peak 2" (small molecule peak, likely sucrose) because the peak saturated the detector; samples were analyzed at a concentration which was appropriate for characterization of the higher molecular weight species, with the expense of saturating the detector with the lower molecular weight species of lesser interest.
• PSD analysis was conducted with a laser diffractor. The measurement calculates a volume distribution from the laser diffraction pattern of a cloud of particles. This raw scatter data is then processed with an algorithm and presented on the basis of equivalent spherical diameter. The results have been summarized on a volume (mass) basis in a histogram giving the differential volume percent less and greater than the indicated size.
• DLS Malvern ® Zetasizer Nano ZS dynamic light scattering
• DLS is an ensemble technique that analyzes the light scattered by particles moving in Brownian motion and generates a particle size distribution based on the particle's rate of diffusion.
• the raw scatter data are processed using a complex algorithm and presented on the basis of an intensity-weighted HYDRODYNAMIC DIAMETER.
• the analytical technique is summarized in ISO 22412:2008 Particle Size Analysis - Dynamic Light Scattering (DLS) as well as ASTM E2490-09(2015) Standard Guide for Measurement of Particle Size Distribution of Nanomaterials in Suspension by Photon Correlation Spectroscopy (PCS).
• NNLS non-negative least squares data
• Z-average average particle size distribution
• 3 PDI polydispersity index
• NNLS non-negative least squares data
• 2 Z-average average particle size distribution
• 3 PDI polydispersity index
• ATOMIC FORCE MICROSCOPY (AFM)
• the as received samples were diluted 50x using MilliQ filtered water (18.2 MO/cm, 4ppb TOC). About 10 pL of these diluted solutions were deposited onto freshly cleaved pieces of mica and allowed to incubate for about a minute. The samples were then rinsed 5x with MilliQ water and dried with nitrogen. Two 1 pm x 1 pm areas were imaged on each sample. The topography differences of these images are presented in colors where the brown is low and the white is high. The z ranges are noted on the vertical scale bar on the right side of the images. Perspective (3-D) views of these surfaces are also included with vertical
• Section analyses were performed to manually measure the heights of representative particles.
• the Sectional analysis for SI at location 1 is shown in Figs. 10, 11, and 12.
• the results are summarized in Table 19 for each of SI, S2, an SB.
• the total organic carbon (TOC) in the samples was calculated by subtracting the inorganic carbon from the total carbon (determined using combustion carbon analyzer). The results are summarized in Table 20 below.
• the osmolality of the samples was measured using vapor pressure method.
• the vapor pressure method determines osmolality at room temperature with the sample in natural equilibrium.
• the results of the osmolality test are summarized in Table 21.
• ICP/OES is a spectroscopic technique used to identify and quantify components by element.
• inductive coupling transfers high-frequency energy to a flow of inert gas, which contains the sample as an aerosol.
• the energy causes the aerosol to vaporize, while exciting the resulting free atoms so that they emit light.
• the intensity of this light is then related to the concentration of the emitting atoms.
• This technique requires calibration of the instrument and a second-source calibration verification before, during, and after completion of the analytical run sequence. In addition, instrument blanks follow each check verification standard. This ensures no carry over during the analytical sequence. Concentration
• FT-IR Fourier Transform Infrared Spectroscopy
• FT-IR Fourier Transform Infrared Spectroscopy
• the infrared absorption bands are assigned to characteristic functional groups. Based on the presence of a number of such bands, a material under consideration can be identified. Availability of spectra of known compounds increases the probability of making a positive identification.
• the lyophilized samples were analyzed by Horizontal Attenuated Total Reflectance (HATR), based on the internal reflection of infrared radiation (IR).
• HTR Horizontal Attenuated Total Reflectance
• IR infrared radiation
• the FT-IR spectrum of SI with a spectral library match is presented in Fig. IS below. The data suggests the material is consistent with sucrose.
• the FT-IR spectra of S2 and S3 are presented in Fig. 14 and Fig. 15. The assignment of the absorption against functional groups are shown in Table 26 - Table 28.
• NMR Spectroscopy is an extremely useful method for material characterization.
• NMR is a physical phenomenon based upon the magnetic property of an atom's nucleus. NMR studies a magnetic nucleus (most commonly that of a hydrogen atom), by aligning it with a very powerful external magnetic field and perturbing this alignment using an electromagnetic pulse. The response to the perturbation is recorded, with each individual nucleus giving a response specific to its chemical, electronic, and spatial environment.
• sample SI and S2 The data indicates that sucrose is present in sample SI and S2, and the chemical shifts match well with those reported in the literature. Note that like the proton spectra, sample S2 seemed to have broadening to a greater extent than sample SI. Finally, the peaks observed in sample S3 match well with literature values for dextran, indicating that is it present in the sample.
• XRD Analysis is a method by which a crystalline inorganic sample is irradiated with monoenergetic x-rays. The interaction of the lattice structure of the sample with these x- rays is recorded and provides information about the crystalline structure being irradiated. The resulting characteristic "fingerprint" allows for the identification of the crystalline compounds present in the sample. Using a whole-pattern fitting analysis (the Rietveld Refinement), it is possible to perform quantitative analyses on samples containing more than one crystalline compound.
• Fig. 22 overlays the XRD raw data from the three samples with small offsets for clarity.
• Sample S2 is different from the other two samples in terms of overall intensities, peak positions as well as peak shape.
• the broad peak shapes in samples SI and SB indicates that these samples consist of a mixture of nano-crystalline and amorphous materials.
• sample SI and S3 were determined to contain a mixture of amorphous and nano-crystalline materials.
• the sodium iron oxide reference pattern was superimposed on these experimental data.
• the markers indicate the location of expected diffraction peaks for each phase and the marker heights indicate the relative peak intensities for a fine-grained, randomly oriented material.
• sample S3 is primarily composed of sucrose and amorphous materials.
• wt% weight percent, ⁇ 5%; 2 average of duplicate preparations (two layers observed)
• FIG. 23 An overlay of the XRD patterns from all four samples (two replicates for SB) is shown in Fig. 23.
• the patterns are offset for clarity.
• the phase identification was performed by comparing the best matches between the background-modelled experimental XRD data to the ICDD/ICSD diffraction database for the sample.
• the reference markers for the phase show where in two-theta the expected experimental peaks should be located and the height of the markers indicates the expected intensity of the experimental peaks, if the sample is fine grained and randomly oriented. Note that XRD is sensitive to crystal structure but relatively insensitive to elemental or chemical state composition. The phase identification for these samples was difficult due the nanocrystalline nature of the samples which significantly broadens peak in the XRD patterns.
• the best matches to the peaks present in all four samples are an iron oxide phase known as maghemite and an iron oxide hydroxide phase.
• the iron oxide hydroxide phase is atypical as it is formed from the heating of beta phase iron oxide hydroxide to about 300°C.
• this reference card does not have the reference intensity ratio (RIR) included which is needed for semi-quantitative analysis.
• RIR reference intensity ratio
• WPF whole pattern fitting
• This technique requires that either the structure factors and atomic locations or the reference intensity ratio (a way of comparing the diffracting power of different phases) are known for all phases identified.
• structure factor which relates to concentration
• lattice parameters which relate to peak position
• peak width and peak shape are refined for each phase to minimize the R value - an estimate of the agreement between the model and the experimental data over the entire pattern.
• UV/Vis Spectroscopy is used to determine analyte concentration either at one time or often over a desired time period.
• the technique measures the absorption of light across the ultraviolet and visible light wavelengths through a liquid sample. Samples are dispensed into a small vial and placed between the path of a UV/Vis light and a detector. According to Beer-Lambert's law, with a constant light path length and known absorption coefficient dependent upon wavelength, concentration of a compound in question can be determined from the light absorbed by the sample at that wavelength.
• TGA consists of measuring the weight change of a material as a function of temperature in a controlled atmosphere. The technique requires precise measurements of weight, temperature, and temperature change. The resulting thermogram generated from the analysis can determine the content of ingredient classes (e.g., solvents, polymers, inorganic fillers, etc.) and thermal stability of polymers. Precision and bias typical of TGA measurements are discussed under ASTM E2040.
• ingredient classes e.g., solvents, polymers, inorganic fillers, etc.
• DSC DIFFERENTIAL SCANNING CALORIMETRY
• DTA DIFFERENTIAL THERMAL ANALYSIS
• DSC Differential Scanning Calorimetry

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