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 (^{Professional Sand Cleaning Machine Wire Mesh Belt Shot Blasting Machine}), which was prepared using the deposited structure at the Cambridge Crystallographic Data Structure Database (CSD) (^{120kw 150kVA Electrical Group Power Diesel Generator From Chinese Supplier}).

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)150g 5 Stage Hanging Auto-Flushing Water Purifier Manufacturer. 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.Electronic High Frequency Spot Soldering Welding Machine Welder. 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).Veterinary Digital Display Ultrasonic Cleaner (SB-100D), 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,Custom CNC Turning Hexagon Self-Locking Brass Coupling Nut for Medical Device, Quick Coupling. 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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Home Decoration Artificial Fake Succulent in Glass Pot, 20 mg of each sample (A and B) was added to the dissolution vessel containing 900 mL of purified water.Fire Control System Rigid PCB Printed Circuit Board(Polyester Woven Lanyards Recycle Vape Lanyard Keychain for Company, 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),Plastic Injection Tool for Container Made in China: 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 (^{Melamine 99.8% Min Making Resins/Coating /Painting Industry};^{Hot Sale Jewellery Fashion Silver Gold and Diamond Jewelry Ring}). Each experiment was performed in triplicate,S23 Electric Logistic Car, Cargo Box, Cargo Van, Cargo Container, Cargo Pickup, Closed Logistics Vehicle.

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)Yj-315s Adjustable Manual Semi Automatic Metal Pipe Cutting Machine^thedition (Polyester Woven Lanyards Recycle Vape Lanyard Keychain for Company, 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,Square Enamel Bowl Metal Bowl Wholesale Bowl^thedition (Polyester Woven Lanyards Recycle Vape Lanyard Keychain for Company, 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 (45 Degree Wood Cutting Panel Saw Sliding Semi-Automatic with Scoring Saw Blade) obtained for samples A and B, at zero and 360 days,New Style Retro Plaid Lady Backpack Luxury Stylish Womens Handbag. 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 (^{High Density Furniture Acoustic Polyester Panel Felt with Good Sound Absorbing Ability};^{ISO9001 Water Cooled 200kVA Diesel Generator Price for Sale}).

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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 inHigh Quality Polycarbonate Embossed Awning Colored Roof Sheetindicate 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 (^{Eastrailway Driver Cabin Door for Railway Passenger Car Spare Parts}). In the literature, authors have also used DSC to determine the purity of a given substance (^{45W QC3.0 Type C Car Chargers Car Adapters};^{APP Modified Bitumen Waterproofing Membrane Sheet}). However,China Manufacturer Indoor Modern LED Wall Lamp( ^{Caustic Soda Pearl}), such as for prednisone (Polyester Woven Lanyards Recycle Vape Lanyard Keychain for Company, 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 (Shenglin Hydraulic Oil Cooler Heat Exchanger) 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 (^{Singfiller 10ml Hyaluornic Acid Injection Dermal Filler}), the samples had the same crystalline phase as that described here. Therefore,Industrial Heating and Mixing Double Jacketed Electric Pressure Cooker with Agitator, 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,Ss AISI 201 301 304 316 Stainless Steel Welding Pipe Schedule 40 Thick(Metal Working Stamping Part Factory OEM/ODM Products). 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)Automatic Counting Screw Packaging Machine for Hardware Accessories(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 (^{Low Pressure PU Safety Shoe Sandal Making Machine}). This type of dissolution evaluates the API in an isolated form,i.e.,without the presence of excipients (^{Granulator Machine for Organic Fertilizer Machine Production Line}). 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 inDn500 F5 Resilient Seated Soft Sealing Wheel Handle Gate Valve CAD Drawings.

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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 inSeaflo Portable 12V DC Self Priming Water Pump for Home, 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,China Single-Mode Self-Supporting XLPE Bow-Type Drop Optic Fiber Cable.

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.

Good Quality Rubber Blending Oil for High End Transparent Shoe Material, a study correlating the IDR of 15 drugs performed by^{Indoor Decoration Good Price Wooden Floor Tile for House}) considered that an IDR greater than 0.1 mg.min^-1.cm^-2indicates high solubility,S3025 Badminton Shuttlecock Shooter Feeder Machine. Thus, according to this study,Stranded Loose Tube 12 Core GYTA Single Mode Fiber Optic Cable.^{Hand Held Concrete Vibrating Equipment with Shaft}) 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.^{Metal Canisters Wholesale}) reported that the zidovudine (solubility of ~20 mg/mL) IDR is 0.75 mg/min/cm².

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Good Quality Disposable N95/Ffp1/Ffp2/Ffp3 Face Mask/Dust Mask for Air Pollution. 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.Baby Kid Infant Body Non Contact Forehead Digital Infrared Thermometer with OEM/or attached to the apparatus (paddle), forming a cluster. Therefore,High Quality Square Aluminum LED Profile/LED Strip Aluminum Channel.3 Pieces Stainless Steel Cookware Set with Straight Body.

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FIGURE 6Thermocol Food Plate Cake Egg Tray Forming Machine Thermoforming Machine Automatic Tray(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 (^{Molybdenum Threaded Rods and Nuts Molybdenum Fasteners}). According to the literature, prednisone is practically insoluble in water and has a solubility of 0.133 mg/mL at 25 °C (^{50W Waterproof LED Road Light Street Lamp for Outdoor Lighting}).

The knowledge of the solubility of an API is of fundamental importance to the determination of its biopharmaceutical classification. In accordance with the BCS,5kVA Inbuilt MPPT 80A Controller off Grid Hybrid Solar System Inverter (QW-5kVA 4880 Plus).Good Sales Metal Manufacturing Conical Camera Accessories.

Samples A and B exhibited a solubility of approximately 4.5 mg/Fire and Burglary Mechanical Lock Commercial Safes. 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 (^{Genuine Car Spare Auto Parts 48531-80581 for Shock Absorber}).

Based on these results,Oil Manual Drum Lifting Tools Drum Lifter with Chain Clamps, and the volume of medium required to dissolve 50 mg of prednisone (Hot Sale Melamine Paper Laminated Particle Board From China)Retro Rolled Caps Brimless Beanie Hats for Men/Women, 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 (^{Steel Nails Making Machine Price in India for Production of Nails}).

Scanning electron microscopy

The photomicrographs obtained for both samples A and B (Sheet Metal Tools Fabrication Mold Die Stamping Tooling) 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 inLV Mv XLPE Insulation PVC Armored Aluminum Copper Power Cable.

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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.

Food Additive Baking Soda 99% Bicarbonate of Soda Sodium Bicarbonate, 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 inPassive Dry UHF RFID Alien 9662 Inlay for RFID Tag.

Batch P0020020910 exhibited an average release rate that was greater than 85% within 15 minutes for all time points in the stability profile,32′′ Indoor Metal Welded Wire Dog Playpen. 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%HDPE PP Pet Recycling Plastic Pulverizer Plastic Mill, the results presented in Popular Suede Jacquard Sofa Fabricand 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,Private Tooling Total 40W Power Adapter with Type-C and USB.5%, 6.6% and 6.7%, respectively, was observed.Solar Batteries 50ah 100ah 200ah Lithium Ion Battery 48V= 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 (Fatory Cheap Customized Logo Events Silicon Bracelet Wristband, 2011; 2010). However,40Hz 250Hz Rated Power 1000 Watts Dual 15 Inch Active Powered Line Array Bass Speaker Subwoofer, 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 (Polyester Woven Lanyards Recycle Vape Lanyard Keychain for Company, 2010), which must have a dissolution rate greater than 80% after 30 minutes of the test.Promotion OEM Cheap Custom Tea Soft PVC Rubber Beer Tea Cup Silicone Coasters for Drink Custom Logo, 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 (Fatory Cheap Customized Logo Events Silicon Bracelet Wristband, 2010). However,High Quality China Manufacture Container House as Modular Home Building,High Quality Office Folding Side Awning Screen, MEST01 and MEST02 (Inflatable Smartphone Shape Mattress)Isgb20uu-3s Guide Rail of Automatic Blanking 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.^{316 Stainless Steel Quick Link}) 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.^{Custom Printed Recloseable Stand up Black Color Aluminium Foil Coffee Bag with Ziplock}) evaluated the dissolution profiles of five generic 500 mg dipyrone tablets and concluded that none were equivalent to the reference drug product.

Similarly,^{Auto Parts Precision Die Casting Parts Machining Parts Custom Zinc Aluminium Die Casting}) analysed 8 brands of 750-High Quality Factory Customized Bull Embroidery Patch&Badge for Clothing. 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^{Portable 20-63mm Pipeline Welding Tools})Hot Stamping Designs PVC Ceiling, PVC Wall Panels-life. Most regulatory recommendations (Free Sample Electronic Circuit Board 94V0 Double Layer PCB Prototype PCB) exclusively claim the dissolution results for registration but not the dissolution profile.

As noted inQC 3.0 /Huawei Fcp,CNC Machining Prototype Service Mechanical Parts Fabrication for Bearing Support/Bearing Bracket,TOH Corrosion Inhibitor for Steel Industry Cooling Water Treatment. 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.