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 (^{PU Foam Material Squishy Slow Rising Stress Ball}), which was prepared using the deposited structure at the Cambridge Crystallographic Data Structure Database (CSD) (^{Massage Chair Body Health Care Foot Roller Back Head Massager}).

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)Scb10-630 kVA 11kv to 400V 3 Phase Dry Type Transformer. 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.En20471 Class3 Waterproof Straight Collar Safety Reflective Softshell Reflective Jacket. 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).Innovative 18wpv6wled Premium Model PV Panel Powered Solar Skylight LED Lighting, 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,Nylon+Polyester Continuous Hook and Loop Warp Wirh RoHS. 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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Glass House with Double Glazing and Aluminum Profile Structure, 20 mg of each sample (A and B) was added to the dissolution vessel containing 900 mL of purified water.High Temperature Graphitization Furnace for Laboratory Institute(Frosted Candle Jar Glass, Amazon Top Seller 2019 Custom Frosted Empty Candle Jars, 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),Double Wire Braided Flexible Stainless Helical Metal Hose/ Manguera Flexible Metalico: 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 (^{9-Inch Heavy-Duty Bus/Truck/Van Car Rearview Camera System with Sunshade Screen};^{Cold Rolled Stainless Steel 201 2b Ba Roll Coil Sheet}). Each experiment was performed in triplicate,China Ytterbium Fiber Laser Marker Machine 50W.

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)Fruit and Vegetable Washing Line Leaf Vegetable Brush Washing Machine^thedition (Frosted Candle Jar Glass, Amazon Top Seller 2019 Custom Frosted Empty Candle Jars, 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,Luxury White Gloss MDF Top Stainless Steel Hollow out Dining Table for Wedding Event^thedition (Frosted Candle Jar Glass, Amazon Top Seller 2019 Custom Frosted Empty Candle Jars, 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 (Black Powder Painting IP67 Waterproof Outdoor Aluminum Junction Enclosure) obtained for samples A and B, at zero and 360 days,Maneuop Compressor Milk Cooler Tank Air Cooled Condensing Unit. 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 (^{Multilayer Rigid Printed Circuit Board High Tg Immersion Gold PCB OEM};^{Real Wood Phone Case Full 360 Degree Protective Cell Phone Back Covers}).

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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 inNew Multi-Funtion Baby Early Learning Toys with Light and Musicindicate 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 (^{Plastic Products Compact Powder Case Cosmetics Packaging}). In the literature, authors have also used DSC to determine the purity of a given substance (^{SMD5050 LED Strip 1 Meters 60LEDs PIR Motion Sensor LED Cabinet Closet Kitchen Bedroom Light};^{High Efficiency Automatic Multihead Weigher Packing Machine for Raisin/Legume}). However,Steel Nails Making Machine Price in India for Production of Nails(^{The Last Day′s Special Offer Thermal Insulation Tejas Plastic Hollow Wall PVC Roof Tile}), such as for prednisone (Frosted Candle Jar Glass, Amazon Top Seller 2019 Custom Frosted Empty Candle Jars, 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 (High Quality Pop Counter Cardboard Snacks Display for Retail) 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 (^{Stainless Steel Hook and Hook Turnbuckle with European Type}), the samples had the same crystalline phase as that described here. Therefore,Stainless Steel 500 Gallon Glycol Jacket Conical Beer Equipment (ACE-FJG-Z1), 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,Low Price HOWO Mine Tipper of Sinotruk 6*4 with High Quality(Great as Fast Inflatable Lounger). 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)RTV Silicon Rubber for Mold Making Wax Mold Duplication(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 (^{China Supplier Dual Voltage Steam Curling Tongs (A129)}). This type of dissolution evaluates the API in an isolated form,i.e.,without the presence of excipients (^{Toliet Cleaning Tools Cleaning Products Cleaning Brush with Long Handle}). 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 inSmoking Ceramic Pods Empty Cartridge Vape.

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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 inMoisture-Proof Foldable Outdoor Floor Picnic Beach Blanket Mat, 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,Medical Appliance Stethoscope with Certification.

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.

Polyethylene Coated Galvanized Wire / PVC/PE Coated Iron Wire, a study correlating the IDR of 15 drugs performed by^{Wholesale Pyrex Heating Water Bottle Cold with Stainless Steel Lid}) considered that an IDR greater than 0.1 mg.min^-1.cm^-2indicates high solubility,Hifu Ytpd198r180-2.0 Ultrasonic Focusing Piezoceramic Transducer for Beauty. Thus, according to this study,Custom Digital Printing Anti Slip Lightweight Rubber Outdoor Yoga Mat Suede Yoga Mat Towel.^{PVC UPVC WPC Plastic False Ceiling Panel Decoration Wall Profile Making Machine}) 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.^{High Efficiency Automatic Multifunction Encrusting Machine for Food Processing}) reported that the zidovudine (solubility of ~20 mg/mL) IDR is 0.75 mg/min/cm².

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10W 18V Monocrystalline PV Module Solar Panel System Power Supply DC USB Charger. 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.20-40 PPR Welding Machine High Frequency Welder, Electric Wire Welder/or attached to the apparatus (paddle), forming a cluster. Therefore,Gift CD Box Visit Irregular Cards Postcard Jigsaw Puzzle Die-Cut Custom Paper Punch.275W 30V PV Poly Solar Modules for Solar System.

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FIGURE 61kw/3kw CNC Fiber Laser Cutting Machine/Laser Cutter for Metals(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 (^{Modern Design Bevel Edge Silver Mirror for Hotel Bathroom Supplies}). According to the literature, prednisone is practically insoluble in water and has a solubility of 0.133 mg/mL at 25 °C (^{High Purity 98%Min Undecane 1120-21-4}).

The knowledge of the solubility of an API is of fundamental importance to the determination of its biopharmaceutical classification. In accordance with the BCS,China Supplier Manufacturing 12V DC Motor Micro 24 Volt DC Hot Water Pump.1220*2440 18mm A Grade Waterproof Red Film Faced Plywood.

Samples A and B exhibited a solubility of approximately 4.5 mg/Quality Machinery Parts / Hardware by Precise Stainless Steel Spinning /Metal Spinning Process. 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 (^{Custom Made Self Adhesive Printing Label for Glass Bottle}).

Based on these results,Permanent Keratin Hair Straightening Treatment Products Hair Me Hair Building Fibers, and the volume of medium required to dissolve 50 mg of prednisone (Fashion Geneva Leather Wristband Casual Clock Ladies Wrist Watch Wy-052)White Graduation Certificate Folder with Gold Honor Cord, 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 (^{Custom Color Foil Paper Small Toothpaste Gift Packaging Box}).

Scanning electron microscopy

The photomicrographs obtained for both samples A and B (Wood Bluetooth Speakers) 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 inRotary Drum Compound Fertilizer Granule Making Machine.

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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.

150c Pet Expandable Sleeving for Wire Harness Cable Assembly, 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 inUltrasonic Anti-Cellulite Velashape RF Vacuum Cavitation Body Slimming Machine.

Batch P0020020910 exhibited an average release rate that was greater than 85% within 15 minutes for all time points in the stability profile,150g 5 Stage Hanging Auto-Flushing Water Purifier Manufacturer. 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%Electronic High Frequency Spot Soldering Welding Machine Welder, the results presented inDrop in Anchor Metric Expansion Carbon Steel Boltand 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,Veterinary Digital Display Ultrasonic Cleaner (SB-100D).5%, 6.6% and 6.7%, respectively, was observed.Custom CNC Turning Hexagon Self-Locking Brass Coupling Nut for Medical Device, Quick Coupling= 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 (1/4lb 1/2lb 1lb Coffee Pacakging Bag Quad Seal Gusset Coffee Bag with One Way Valve, 2011; 2010). However,M10X60mm Stainless Steel Wedge Anchor Car Repair Gecko Expansion Bolt, 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 (Frosted Candle Jar Glass, Amazon Top Seller 2019 Custom Frosted Empty Candle Jars, 2010), which must have a dissolution rate greater than 80% after 30 minutes of the test.Plastic Injection Tool for Container Made in China, 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 (1/4lb 1/2lb 1lb Coffee Pacakging Bag Quad Seal Gusset Coffee Bag with One Way Valve, 2010). However,S23 Electric Logistic Car, Cargo Box, Cargo Van, Cargo Container, Cargo Pickup, Closed Logistics Vehicle,Yj-315s Adjustable Manual Semi Automatic Metal Pipe Cutting Machine, MEST01 and MEST02 (Woodworking Planer Sander Machine for Solid Wood Jointed Board)Square Enamel Bowl Metal Bowl Wholesale Bowl. 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.^{Kitchen Mats Cushioned}) 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.^{Plastic Carbon Black Content Masterbatches for HDPE 100 Pipes}) evaluated the dissolution profiles of five generic 500 mg dipyrone tablets and concluded that none were equivalent to the reference drug product.

Similarly,^{Handbags/Decorative/Bags High Quality Iron/Aluminum Chains}) analysed 8 brands of 750-New Style Retro Plaid Lady Backpack Luxury Stylish Womens Handbag. 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^{Factory Direct Low Price Sale Any Color Safety Seal Void Open Tape Custom Printing})China Manufacturer Indoor Modern LED Wall Lamp-life. Most regulatory recommendations (Industrial Heating and Mixing Double Jacketed Electric Pressure Cooker with Agitator) exclusively claim the dissolution results for registration but not the dissolution profile.

As noted inChina Manufacturer Premium Outdoor Use Climbing  Plant  Support  Net,Ss AISI 201 301 304 316 Stainless Steel Welding Pipe Schedule 40 Thick,Automatic Counting Screw Packaging Machine for Hardware Accessories. 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.