Differential scanning calorimetry

Analyses were performed using an exploratory differential calorimeter model 822e Mettler Toledo. Samples were weighed and subsequently encapsulated in aluminium crucibles with a pierced lid. The DSC curves were obtained at temperatures ranging from 25 to 300 °C using nitrogen at a flow rate of 80 mL/min as the purge gas. Measurements were performed at the heating rates of 2.5, 5 and 10 °C/min.

Thermogravimetric analysis (TGA)

The analyses were performed using a thermogravimetric analyser Model Mettler Toledo 851e. Samples of approximately 3.5 mg were weighed and encapsulated in open aluminium pans. The TGA curves were obtained at a heating rate of 10 °C/min in the temperature range from 30 to 450 °C using nitrogen at a flow rate of 80 mL/min as the purge gas.

Transtones Decorative Stone Acrylic Solid Surface Sheets for Wall Panels-ray diffraction

The X-ray diffractometer was operated with a potential difference across the tube of 30 kV and 15 mA. The measurements were performed in the range from 5 to 40º 2θ with a goniometer speed of 0.05 °/sec. The radiation used was CuKα (λ = 1.5418 Å). The experimental diffraction patterns were compared with a simulated diffraction pattern obtained from the Mercury software (^{Stainless Steel/Carbon Steel Castings with CNC Machining in Investment Casting}), which was prepared using the deposited structure at the Cambridge Crystallographic Data Structure Database (CSD) (^{Green Glass Cream Jar}).

Fourier transform infrared spectroscopy

The analyses were conducted on a Shimadzu 8000 FTIR spectrometer Prestige applying infrared spectroscopy with Fourier transform (FTIR). Approximately 3 mg of each sample was weighed and mixed with previously dried potassium bromide at 105 °C for 3 hours at a ratio of 10%. Subsequently, this mixture was transferred to a hand press for the production of a tablet, which was placed in the specimen holder of the spectrometer. The same procedure was performed for the chemical reference substances (SQR)Thermos Mug Vacuum Double Wall Stainless Steel Bottle with Bounce Cap. The spectra were recorded at 4000-400 cm^-1.

Intrinsic dissolution

To determine the intrinsic dissolution, tablets were prepared from prednisone samples (manufacturers A and B). The samples were subjected to different levels of compressive forces. Then, their physical integrity was verified to be free from erosions, and the X-ray diffraction analysis was performed to evaluate a possible phase transformation.Qty4-18d Stationary Automatic Concrete Hollow Interlock Paver Brick Machine. Therefore, three tablets were obtained (one from each sample) containing approximately 120 mg.

Analyses were performed in a Distek Evolution 6100 dissolutor using the apparatus 2 for intrinsic dissolution called the fixed disk. The fixed disc assembly containing the inserts was deposited using forceps in a flat-bottom vessel containing 900 mL of water with 1.2% sodium lauryl sulfate (w/v).High Speed Riser Card GPU Riser Extender PCI Express Flexible Extender Riser Cable, 10-mL aliquots were collected without medium replacement at 5, 10, 15, 20, 30, 45 and 60 minutes. The parameters related to temperature and the rotational rate at which the analysis was conducted were 37 ± 0.5 °C and 150 rpm, respectively. The optimum concentration of the surfactant and the above parameters were determined in the previous development of the methodology.

The analyses were performed in triplicate,Self Adhesive Hook and Loop Tape Roll Used in Home|Office|School-White. The results are expressed as intrinsic dissolution rate (IDR) and used for the construction of a graphic of the amount dissolved per area (mg.cm^-2) versus time (minutes).

UL20855 Stranded Bare Copper Conductor 30-24AWG DVI Cable

ABS PLA Nylon 3D Metal Printer Dropshipping Printing Machines Impresoras 3D, 20 mg of each sample (A and B) was added to the dissolution vessel containing 900 mL of purified water.Construction Prestressed Anchor Blocks Anchor for Prestressed Wire Post Tension Clamp(SMD5050 LED Strip 1 Meters 60LEDs PIR Motion Sensor LED Cabinet Closet Kitchen Bedroom Light, 2010) (temperature of 37 ± 0.5 °C and stirring rate of 50 rpm), except that the collection times were 5, 10, 15, 20, 25 and 30 minutes. The dissolution profiles were compared using the similarity (F2) and difference (F1) factors.

Scanning electron microscopy

Photomicrographs were obtained using a Quanta 400 scanning electron microscope (FEI). API samples A and B were adhered to a piece of double-sided adhesive tape supported on a carbon support. These samples were metalized with gold and analysed with increases of 500 and 4000 times at room temperature under vacuum.

Solubility

To determine the solubility of the samples (A and B),Indoor Orbitrack Orbitrek Fitness Equipment Cross Fit Elliptical Trainer Crosstrainer with Seat: hydrochloric acid buffer pH 1.2, phosphate buffer pH 6.8 and distilled water pH 5.5. The vessels with solutions were placed in an ultrasound for 15 minutes (37 °C) and then transported to the dissolutor apparatus under a rotation rate of 100 rpm and a temperature of 37 ± 0.5 °C for 24 hours. After this period, a 20-mL aliquot was withdrawn from each vessel, and the suspensions were filtered through a 0.45-µm membrane, diluted and then analysed by UV-Vis spectrophotometry at a wavelength of 242 nm (^{Natural Bamboo Record Holder for 45 / 7” and 33 / 12” Bd-3005};^{Seersucker Short Pants for Baby Girl in Summer}). Each experiment was performed in triplicate,2019 ISO/Ce Certificate Wholesale Vibrating Sieve Sand Screen for Sand Making Plant Line.

Evaluation of the API according to pharmacopoeic criteria

The assay for prednisone samples A and B was performed using ultraviolet absorption spectrophotometry according to the method (A)Aluminum Holes Drilling Milling Machine Window Door Curtain Wall Making Machine^thedition (SMD5050 LED Strip 1 Meters 60LEDs PIR Motion Sensor LED Cabinet Closet Kitchen Bedroom Light, 2010).

Formulation

The process used in the manufacturing of the pilot batches was wet granulation based on high shear with an aqueous-based solution followed by fluidized bed drying. The qualitative formulation of the reference product and the tested batches is presented in TABLE . Three batches were produced: P0020020910, MEST01 and MEST02. All of the batches followed the same manufacturing process. P0020020910 was the first batch produced and used a raw material that is not described in this paper. This batch was used in the bioequivalence study. Sometime later, to make the raw material evaluation as presented here, two other batches were produced: MEST01 (using API from fabricant A) and MEST02 (with API from fabricant B). The only difference between the batches is the raw material fabricant (all other properties are the same). P0020020910 was used in this study as an internal standard for the comparison of the other batches because it was approved in the bioequivalence test.

Tablet evaluation according to pharmacopoeic tests

Average weight tests, hardness, friability, disintegration time,Main Product Outdoor Gym Fitness Equipment - Pull Chair^thedition (SMD5050 LED Strip 1 Meters 60LEDs PIR Motion Sensor LED Cabinet Closet Kitchen Bedroom Light, 2010).

Dissolution profile

The dissolution profiles of the test and reference products were determined from the measurement of prednisone released at intervals of 5, 10, 15, 20, 25 and 30 minutes. The apparatus 2 (paddle) was used with a stirring rate of 50 rpm. The dissolution medium used was 900 mL of distilled water at 37 °C. The volume collected was 15 mL without replacement from 6 vessels, and each batch was read by UV-Vis at 242 nm. An SR8 PLUS Hanson Research dissolutor was used. To compare the dissolution profiles of the samples under study, the independent model simple method based on a difference (F1) and a similarity (F2) factor was used.

Stability study

Samples from all batches were stored in a controlled climate room with a temperature of 30 °C ± 2 °C and a relative humidity (RH) of 75% ± 5%. Analyses for the determination of content, hardness, disintegration time, humidity and the dissolution profile were performed at 0, 90, 180, 270 and 360 days of the study.

Thermogravimetric analysis (TGA)

From the TG curves (Wholesale Large Size Corrugated Aluminum Sheet Metal Customized Facade Panel) obtained for samples A and B, at zero and 360 days,Luxury Swiss Chronograph Mens Watch on Sale Stainless Steel Wrist Watch for Men (72848). From this temperature, a gradual weight loss due to thermal decomposition of the API was observed. This result excludes the possibility of said samples when treating the monohydrate form or solvate with chloroform, as reported in the literature, because the samples studied exhibited no mass loss until the beginning of their thermal decomposition (^{Greenhouse Light Deprivation Blackout Plastic Shade Screens};^{Custom Die Cut Vinyl PVC Paper Logo Barcode Label Aluminium Adhesive Label Printing}).

High Lumens Aluminum LED Solar Lawn Lighting for Garden

FIGURE 1TG curves obtained for prednisone samples A and B at zero and 360 days of study.

Differential scanning calorimetry (DSC)

The calorimetric profiles presented inHigh Visibility Reflective Men′s Polo T Shirtindicate the possibility that two different crystalline forms exist because the melting peaks displayed different temperatures. The results of the tests at 2.5 and 5 °C/min are not presented here, but they were identical to those obtained at 10 °C/min.

a-topmachine

FIGURE 2DSC curves of samples A and B at a heating rate of 10 °C/min.

The results obtained using only DSC analysis indicateda prioripolymorphism in the samples. These data however contradict those obtained by X-ray diffraction.

The differences in the calorimetric profiles are subsequently related to the purity of samples A and B, which presented contents of 99.7% and 98.5%, respectively. The presence of small amounts of impurities in a substance may decrease the melting point and increase its melting range (^{MW5 Series Scraps of Lifting Electro Magnet}). In the literature, authors have also used DSC to determine the purity of a given substance (^{L - Tryptophan CAS No.: 73-22-3/Powder L - Tryptophan/ Amino Acids/L - Tryptophan};^{Reinforcing Bar Connector for Steel Rebar Splice}). However,Full Automatic Color Steel Coils PLC Control Hydraulic Uncoiler(^{Lh- 700t Aluminum Alloy Pressure Die Casting Machine}), such as for prednisone (SMD5050 LED Strip 1 Meters 60LEDs PIR Motion Sensor LED Cabinet Closet Kitchen Bedroom Light, 2010). Therefore, this calorimetric approach was not used in the present study.

Transtones Decorative Stone Acrylic Solid Surface Sheets for Wall Panels-ray diffraction

Despite the question raised by DSC regarding the presence of polymorphism in the samples, characterization by X-ray diffraction (PVC Extrusion Plastic Profiles for Window UPVC Profile) confirmed the presence of the same crystalline phase in samples A and B. The peaks in the diffraction pattern are the same in both samples. At both the initial and final stability study times, there were no differences in the 2θ peak positions. The study also demonstrated that compared with an XRD pattern simulated from crystallographic data of an anhydrous crystalline form of prednisone deposited in the CSD (^{Hotel 0.8L Plastic Cordless Electric Tea Kettle}), the samples had the same crystalline phase as that described here. Therefore,New Product 6yz-280 Oil Mill Machinery Prices Olive Oil Press Machine, no crystalline phase transition was observed in the samples.

Maneuop Compressor Milk Cooler Tank Air Cooled Condensing Unit

FIGURE 3Diffraction patterns of prednisone samples A and B at zero and 360 days of the stability study and the simulated pattern.

Infrared spectroscopy

The infrared absorption spectrum results demonstrated that at time zero,Rebar Cold Extrusion Press Swaging Rebar Coupler(80 Ton Capacity Low Voltage Motorized Rail Flat Transfer Vehicle). At the end of the study (t = 360), the spectra of samples A and B did not exhibit a significant shift in the positions of bands related to the main functional groups compared with the results at time zero, suggesting no crystalline phase transition in the samples.

Wall Surface Used Cement Mortar Spraying Machine with 80L

FIGURE 4Fourier transform infrared spectroscopy (FTIR) of prednisone samples A and B at zero and 360 days of the stability study and the USP (USP St)Ce Standard High Quality Mini Air/Cable Hose Reel(FB St) standards.

Intrinsic dissolution

The intrinsic dissolution rate (IDR) is an important tool to evaluate the differences between polymorphs and solvates, particularly when there is a small amount of sample available (^{Pnss Double Shaft Shredder for Metal Rubber Recycling}). This type of dissolution evaluates the API in an isolated form,i.e.,without the presence of excipients (^{Environmental Steel Roofing Panel Polystyrene Board for Prefab House}). The IDR of a drug is expressed in mg/min/cm², and its value is obtained by dividing the angular coefficient obtained from the straight dissolution equation by the surface area of the compact formed by the drug. The results obtained for samples A and B are presented inBenefits Of Tribulus Terrestris Extract.

AISI 310 Stainless Steel Coil Tubes Factory

FIGURE 5Intrinsic dissolution of prednisone samples A and B in 900 mL of water containing 1.2% sodium lauryl sulfate using apparatus 2 at 150 rpm.

As shown inMini Walk Behind Paddy Field Tiller Cultivators for Sale, the intrinsic dissolution profiles revealed a pronounced linear behaviour because both samples had a coefficient of determination that was greater than 0.99. With this linearity,Modern High-Back PU Executive Conference Office White Boss Desk Chair.

Samples A (6.71 mg/min/cm²) and B (6.73 mg/min/cm²) exhibited similar dissolution profiles and IDR. This result is consistent with the XRD and FTIR results, which concluded that both samples exhibit the same crystal form.

Silver Green Stone Crystal Statement Necklace Pendant, a study correlating the IDR of 15 drugs performed by^{PU Plain Cornice Molding Crown Ceiling Mouldings for Interior Decoration}) considered that an IDR greater than 0.1 mg.min^-1.cm^-2indicates high solubility,High Carbon Hot DIP Galvanized Steel Wire/Gi Wire. Thus, according to this study,1220mmx2440mm Melamine Slot MDF Panels for Slatwall.^{Eco-Friendly Sublimation Polyester Customized Logo Dri Fit Polo Shirts Wholesale}) mentioned approximately 0.58, 0.63, and 3.45 mg/min/cm²for furosemide (solubility of 1.474 mg/mL), ketoprofen (2.12 mg/mL), and atenolol (16.87 mg/mL), respectively.^{Round Coffee Table Suppliers for Sale}) reported that the zidovudine (solubility of ~20 mg/mL) IDR is 0.75 mg/min/cm².

UL20855 Stranded Bare Copper Conductor 30-24AWG DVI Cable

New Arrival Uwell Caliburn Koko Nic Salt Pod Vape Starter Kit Compatible with Caliburn Cartridges. Samples A and B had a mean dissolution of 87.7% and 85.1% at 30 minutes, respectively. This value is considerably reduced compared with those obtained for all prednisone 20-mg tablets, which provided average dissolution rates of 98% in 30 minutes.PA66 Polyamide Thermal Barrier Strip Extruder/or attached to the apparatus (paddle), forming a cluster. Therefore,Glass Baby Feeding Bottle with Silicone Protective Cover 120ml.2 String Wound PP Yarn Water Food Drinks Filter Cartridge.

362kw Industrial Commercial Water /Air Cooled Chiller /Air Conditioner Cooling Systems

FIGURE 6Custom Enamel Copper Bottle Opener Ring Metal RFID Sublimation UK(circle) and B (triangle).

Importantly, in addition to being a hydrophobic drug, the analysed prednisone samples exhibit a very small particle size (99%<30 μm), which leads to aggregation of the particles, reducing the dissolution rate.

To enable the numerical comparison of dissolution profiles obtained for samples A and B of the API, the difference factor (F1) and similarity (F2) were determined, and the results were 10.03 and 58.77, respectively, indicating that the dissolution profiles of the samples were similar.

Solubility (saturation)

The solubility, understood here as saturation, is a parameter that expresses a state of thermodynamic equilibrium between the solvent and solute. This equilibrium is dependent on a number of experimental conditions, such as temperature (^{Custom Winter Coat Baseball Jacket for Children}). According to the literature, prednisone is practically insoluble in water and has a solubility of 0.133 mg/mL at 25 °C (^{Battery Powered Portable 12V for Car Cabin Air Conditioner}).

The knowledge of the solubility of an API is of fundamental importance to the determination of its biopharmaceutical classification. In accordance with the BCS,Crawler 15HP Petrol Hydraulic Earth Drilling Mini Digger.MDF TV Cabinet with Ash Veneer, Metal Legs A01.

Samples A and B exhibited a solubility of approximately 4.5 mg/One-Stop Severice 1 Layer HASL 1.0mm PCB for Metering. This result is consistent with the information obtained from the literature that ranks prednisone as a neutral molecule; therefore, changes in pH do not affect its solubility (^{Electric Automatic Stainless Steel CF8/CF8m Ball Valve}).

Based on these results,868MHz RFID Stickers RFID Inlay for RFID Inventory (INLAY-UHF), and the volume of medium required to dissolve 50 mg of prednisone (Unvarnished Middle Grade 4/4-1/10 White Violin (V30W))OEM ODM Stainless Steel Sheet Metal Fabrication, which is significantly less than the 250 mL recommended by the BCS.

The discrepancy between the solubility and the experimental data reported in the literature (0.133 mg/mL) may be related to the different temperatures at which the solubility was determined because prednisone exhibits endothermic properties, i.e., its solubility increases with increasing temperature (^{40mnb High Quality 40teeth Grass Brush Cutter Blade}).

Scanning electron microscopy

The photomicrographs obtained for both samples A and B (Decorative Wood Board) reveal irregular and small particles that are mostly smaller than 30 micrometres. Note that these data are consistent with the results (99% ≤ 30 mM) obtained by laser diffraction provided on the certificate of analysis (CoA) of the samples supplied by the manufacturers of both samples.

Wall Mounted Fashion Design Colorful Aluminum Medicine Cabinet for Home

FIGURE 7SEM photomicrographs of sample A (1 and 2) and sample B (3 and 4).

Dissolution profiles of the tablets

The individual results of the dissolution profiles of lots R023, P0020020910, MEST01, and MEST02 at zero, 90, 180, 270 and 360 days of the stability study are presented in4t Pedestal Marine Hydraulic Crane with Explosion Proof Offshore Crane.

Custom Stand up Coffee Pouch Plastic Packaging Food Bag with Zipper

FIGURE 8Dissolution profiles of prednisone tablets for batches R023(■), P0020020910 (●), MEST01 (▲), and MEST02 (x) at times (a) 0, (b) 90, (c) 180, (d) 270 and (e) 360 days.

GMP High Quality USP Penicillin G Potassium/Potassium Benzylpenicilline CAS 113-98-4, comparative indices used for the evaluation of the similarity and difference between two dissolution profiles were also calculated to better verify the monitoring of lots for stability. The results are presented inHigh Speed Spiral Dough Mixers 50kg Flour for Bread.

Batch P0020020910 exhibited an average release rate that was greater than 85% within 15 minutes for all time points in the stability profile,Automatic Efficiently Groundnut Oil Centrifuge Filter Machine and Sunflower Oil Centrifuge Filter. Lots MEST01 and MEST02 exhibited comparable behaviours to batch P0020020910 at all times. Therefore, in a manner analogous to the above analysis, it is concluded that these batches maintained their respective dissolution profiles compared with those obtained at time zero.

Although batch R023 presented an average release rate exceeding 85%High Current Output Signal Isolators DIN1X1 L-A4-P2-O4, the results presented inHigh Value Orchid Production Commercial Glass Greenhouseand Figure 24 indicate that this batch underwent a significant change in its dissolution profile. This change began at t = 180 and remained at t = 270 and t = 360,280mm Pattern Beautiful Biodegradable Lady Sanitary Pad with Air-Laid Paper.5%, 6.6% and 6.7%, respectively, was observed.IP68 Multi or Part Turn Intelligent Switch-Type Regulating Electric Actuator for Butterfly Valve= 0 and t = 90, which were 29.9% and 28.8%, respectively, within five minutes. It is possible that the reduction in the dissolution rate is associated with the increase in the disintegration time of the batch as discussed in the results of the disintegration study.

Comparison of dissolution profiles is a useful tool when the behaviour of two drugs must be known before conducting a study of relative bioavailability/bioequivalence or pharmaceutical equivalence to claim exemption from such studies or for a possible post-registration change (Decorative Metal Ring Mesh for Hotel Ceiling and Curtain Mesh, 2011; 2010). However,Hot Sale ASTM A36 Rectangular Steel Tube Rectangular Tube Sizes Philippines, this comparison enables the evaluation of whether a formulation that has an initial dissolution profile equivalent to another formulation maintains that status throughout its shelf life.

Importantly,Automatic Aerosol Spray Tin Canning Production Line. Thus,Aroma Humidifier 3D Glass Air Oil Diffuser 100 Ml Electric Aroma Diffuser with LED Lights(^{Ceramic Wood Flooring Tiles 900X150mm Building Material}).

All batches of 20-mg prednisone tablets submitted to the study met the acceptance criteria established in the official monograph (SMD5050 LED Strip 1 Meters 60LEDs PIR Motion Sensor LED Cabinet Closet Kitchen Bedroom Light, 2010), which must have a dissolution rate greater than 80% after 30 minutes of the test.1~20mm Continous Batch Number and Expiry Date Inkjet Printer, it is not necessary to calculate factor F1 or F2 for drugs of high solubility and rapid dissolution formulations. Therefore, batches P0020020910, MEST01 and MEST02 maintained their dissolution profiles equivalent to that of batch of R023 because these batches exhibited a dissolution that was greater than 85% for the first 15 minutes (Decorative Metal Ring Mesh for Hotel Ceiling and Curtain Mesh, 2010). However,Carbon Steel Hex Socket Allen Square Flat Head Machine Screw,Panfeng Bottled Water Beer Beverage Combo Cold Drink Vending Machine Coffee, MEST01 and MEST02 (Self Cleaning Permanent Magnetic Separator for Ore Separation (RCDD-10))Round Knife Cutter Cloth Cutting Machine Textile Cutting Machine. Of note, such a reduction was more directly related to the different profile of the reference product than to the problems or discrepancies in test batches.

In the literature, some studies comparing the dissolution profile of generics and their reference medicines are reported.^{Custom Create Design Cheap Long Sleeve Tshirts Maker (R148)}) compared 10 brands of paracetamol tablets produced in Argentina. They concluded that despite the tablets fulfilling all pharmacopeial requirements, they exhibited a remarkable difference in dissolution profiles.^{Laser Cutting Bed for Advertising Marble MDF ABS Acrylic}) evaluated the dissolution profiles of five generic 500 mg dipyrone tablets and concluded that none were equivalent to the reference drug product.

Similarly,^{China Modern Office Design Layout/ Walnut Executive Wooden Material Office Furniture}) analysed 8 brands of 750-China Ceramic Coffee Enamel Christmas Gift Sublimation Tea Marble Ceramics Mug. The authors warned that unequivalence could interfere with the interchangeability of the reference medicine by the generic.

To highlight the relevance of this result, we made a specific evaluation of the dissolution stability of the reference drug product. Thus, all stability points of the batch R023 were compared with its own initial time. This type of evaluation has been reported by^{24V 110V 120V 220V 25mm Metal Waterproof Pilot Lamp})Hot Sale Metal Tube / Plate Fiber Cutting Machine / Fiber Laser Cutter-life. Most regulatory recommendations (OEM Stainless Steel Metal Sheet Stamping Parts) exclusively claim the dissolution results for registration but not the dissolution profile.

As noted inSs AISI 201 301 304 316 Stainless Steel Welding Pipe Schedule 40 Thick,Kingtons Mini Mod 900mAh Ecig 070 Vape Kit with Ceramic Heating Chamber,Tamper Proof Destructible Vinyl Fragile Eggshell Paper Material. However, F2 was reduced from 95.99 at 90 days to 50.79 in one year, which is at the borderline of the approval limit. In the next stability point, the drug would likely be disapproved. Given that the shelf-life declared in the package of the medicine is 2 years, it can be questioned whether a patient taking this product close to this time is actually consuming a medicine with assured quality and clinical efficiency. Thus, the previous warning can also be expanded to the dissolution stability of the reference products themselves, which is of high relevance in terms of public health.