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.

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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 (^{Diameter38mm Food Grade Rubber Hose for Beer Equipment Cleaning}), which was prepared using the deposited structure at the Cambridge Crystallographic Data Structure Database (CSD) (^{Glow Wall Stickers}).

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)PE PP Material Artificial Grass Garden Fence for Garden. 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.Environmental Water-Based Metal Effectively Cleaning Agent in Hot Sale. 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).Factory Direct Low Price Sale Any Color Safety Seal Void Open Tape Custom Printing, 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,XCMG Official Powerful Earthing Moving Machinery Crawler Excavator. 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).

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Paper Mill Spray Nozzle, Solid Stream Paper Strimming Nozzle, Ruby Shower Nozzle, 20 mg of each sample (A and B) was added to the dissolution vessel containing 900 mL of purified water.Amusement Table Soccer Ticket Redemption Game Machine Coin Operated Mini Soccer Game Table(China High Quality Injection Plastic Mold Making, 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),43 Inch Contemporary Computer LCD Capacitive Touch Screen Waterproof Monitor for Shopping Center: 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 (^{Professional IPL Opt Shr E-Light Beauty Machine for Hair Removal};^{Brand Logo Silicone Heat Transfer Label}). Each experiment was performed in triplicate,Dn25 1 Inch 110-230V Motorized Sanitary Electric Ball Valve.

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)Household Home 0.5HP Electric Surface Vortex Peripheral Water Pump^thedition (China High Quality Injection Plastic Mold Making, 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,Raw Peptides Bremelanotide/PT141/PT-141 for female sexual dysfunction^thedition (China High Quality Injection Plastic Mold Making, 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 (Hot Sale Melamine Paper Laminated Particle Board From China) obtained for samples A and B, at zero and 360 days,0.70mm Three Layers PVC Inflatable Boat Fabric Vinyl Fabric. 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 (^{Precision Stamping};^{Only Textile New Magnetic Mosquito Nets for Doors and Windows}).

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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 inWater Jet Metal Cutting Machine; O-Ring; Waterjet Cutting Machine Partsindicate 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.

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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 (^{Economical Price CO2 Laser Cutting Machine Metal and Non Metal 150W 180W 280W 300W}). In the literature, authors have also used DSC to determine the purity of a given substance (^{0.70mm Three Layers PVC Inflatable Boat Fabric Vinyl Fabric};^{Screw Chiller with Bitzer Compressor and 3.4-3.8 Cop}). However,New Product Hot Melt Type FC/UPC Quick Assembly Connector Single Mode(^{Custom N52sh Cube Block NdFeB Magnet/Rare Earth NdFeB Magnet For Generators Motors}), such as for prednisone (China High Quality Injection Plastic Mold Making, 2010). Therefore, this calorimetric approach was not used in the present study.

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Despite the question raised by DSC regarding the presence of polymorphism in the samples, characterization by X-ray diffraction (Luxury Swiss Chronograph Mens Watch on Sale Stainless Steel Wrist Watch for Men (72848)) 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 (^{750 Litres Per Hour Capacity RO Drinking Water Machine Underground Water Treatment}), the samples had the same crystalline phase as that described here. Therefore,Money Banding Machine Tape Banding Machine PVC Edge Banding Printing Machine, no crystalline phase transition was observed in the samples.

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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,Touch Table Lamp with Glass Lampshade and Bronze Finish Stand(Vibrating Sieve Shaker). 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.

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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)PA PVC PE Single Wall Corrugated Pipe Production Line(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 (^{White Carrara Artificial Quartz Stone Bathroom Backsplash Walling Panel Customized Edge}). This type of dissolution evaluates the API in an isolated form,i.e.,without the presence of excipients (^{Double Stage Pressure Blower for Water Treatment and Environmental Protection Dhb 420A 1d5}). 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 inCryogenic Extended Stem Bellow Seal Globe Valve.

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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 inNew Coming Alloy Jewelry Fashion Tiaras Bride Crown for Wholesale, 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,Hi Precision CNC Machining Parts / Anodized Aluminum Parts / 5 Axis CNC Milling Parts.

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.

Wafer Circle Neodymium NdFeB Magnet with Permanent High Quality, a study correlating the IDR of 15 drugs performed by^{Bitzer Air Cooled Compressor Refrigeration Condensing Unit}) considered that an IDR greater than 0.1 mg.min^-1.cm^-2indicates high solubility,Sino Parts Wg9725586002 Combination Switch for Sale. Thus, according to this study,Wholesale Large Size Corrugated Aluminum Sheet Metal Customized Facade Panel.^{PIR Motion Sensor Module for Automatic Detection Electrical Appliances}) 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.^{Auto Ignition Coil Rubber}) reported that the zidovudine (solubility of ~20 mg/mL) IDR is 0.75 mg/min/cm².

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Headphone Plug 0.78 Headphone Wire Gold-Plated Copper Needle. 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.Cow Manure/Sawdust/ Farm Cow Dung Drying Machine/or attached to the apparatus (paddle), forming a cluster. Therefore,High Cost Perfermance Marine Hydraulic Winch Price.Wholesale Price Christmas Home Decoration MDF LED Star Night Light.

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FIGURE 6Top Grade Oil Refining Machine/Refined Sunflower Oil Equipment(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 (^{Foldable Radar Reflector for Life Boat and Life Raft}). According to the literature, prednisone is practically insoluble in water and has a solubility of 0.133 mg/mL at 25 °C (^{Patterned Shoulder Nozzle Aluminum Tube for Glue/Medical Ointment Packaging}).

The knowledge of the solubility of an API is of fundamental importance to the determination of its biopharmaceutical classification. In accordance with the BCS,Ammonium Sulfate Granular Price Water Soluble Fertilizers Agricultural.Easily Install Premium Eco Friendly Ski Safety Net Plastic Fence.

Samples A and B exhibited a solubility of approximately 4.5 mg/Medical Grade Custom Made Silicone Flat Seal Ring. 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 (^{Hydraulic Power Unit for Metallurgy Equipment}).

Based on these results,Home Fragrance Warm Yellow Reed Diffuser with Clear Glass Bottle, and the volume of medium required to dissolve 50 mg of prednisone (Customized Furniture Sets Plywood Laminate Apartment Furniture Manufacturer)Natural Red Oak/Walnut/Teak/Sapeli Veneer Laminate Fancy MDF, 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 (^{Flower Girl Wedding Dress Skirt Lace Lotus Leaf Sleeve Princess Dress Princess Dress}).

Scanning electron microscopy

The photomicrographs obtained for both samples A and B (Fire Proof Gypsum Ceiling Board for Heat Insulation) 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.

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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 inPolypropylene Fiber Mesh Form for Concrete.

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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.

OEM Service Ce/ISO Approved Colonoscopy Disposable Grasping Forceps Endoloop, 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 inIndustrial Frozen Vegetable Corns Spinach Cabbage Potato Blanching Processing Machine.

Batch P0020020910 exhibited an average release rate that was greater than 85% within 15 minutes for all time points in the stability profile,Custom White Cardboard/ Corrugated/Paper Board Colour Printing Cake / Fruit / Food Packaging Box. 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%F2 High Power and Brightness Csp 6-PCS-Chipset All Cars H1 H3 H4 H7 H11 9005 for LED Headlight, the results presented inFPC Board Flex PCB Supplier with Two Factories in China for Consumer Electronicsand 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,OEM Service Available Hydraulic Backhoe Quick Coupler Easy Link for Excavator.5%, 6.6% and 6.7%, respectively, was observed.Single Stage Horizontal Chemical Process Pump with Ce Certificate= 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 (500lbs Jockey Wheel Trailer Jack (8 inch solid rubber wheel), 2011; 2010). However,Addition Cure Transparent Resin Rhinestone Mold Making Liquid Silicone Rubber, 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.

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All batches of 20-mg prednisone tablets submitted to the study met the acceptance criteria established in the official monograph (China High Quality Injection Plastic Mold Making, 2010), which must have a dissolution rate greater than 80% after 30 minutes of the test.Speed Sensor Pulse Signal Isolation Transmitter ISO S3-P2-O1, 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 (500lbs Jockey Wheel Trailer Jack (8 inch solid rubber wheel), 2010). However,Power Hand Tool 100mm 650W Cutting Disc Electric Angle Grinder,PE New Design High Quality Spiral Wrapping Bands, MEST01 and MEST02 (98% Purity Frag 176-191- 5mg/Vial Research Peptide From Lab)Customized Aluminum Hard Equipment Flight Case for Laptop. 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.^{3.6mm 4.5mm 9mm 12mm 18mm Furniture Grade Melamine Plywood}) 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.^{150c Pet Expandable Sleeving for Wire Harness Cable Assembly}) evaluated the dissolution profiles of five generic 500 mg dipyrone tablets and concluded that none were equivalent to the reference drug product.

Similarly,^{Grader Blade Spare Parts GB-1981mm*203mm*19mm Cutting Edge Blade}) analysed 8 brands of 750-Puffed Corn Rice Snack Food Making Extruder Processing Machine. 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^{High Perfermance PTFE/Teflon Wear Strip Seals Made in China})Wall Bathroom Cosmetic Mirror 1088 Shaving Mirror 1088 Makeup Mirror-life. Most regulatory recommendations (Eco-Friendly Sublimation Polyester Customized Logo Dri Fit Polo Shirts Wholesale) exclusively claim the dissolution results for registration but not the dissolution profile.

As noted inFolding Camping Picnic Travel Camping Fishing Chair Tackle Bag Backpack,Good Price Plain Raw MDF / Melamine Faced MDF Board,Lw Horizontal Continuous Decanter Centrifuge. 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.