Plumbing Pipe Water Pipe Suppliers of Gas 316 Pipe 304 Stainless Steel Gas Pipe Accessories
Air-Sealed Inflatable Military Tent with Windows
INTRODUCTION
Prednisone is a glucocorticoid that is extensively used in clinical practice (China Direct Copper Phosphor Brazing Welding Ring Alloy Free Samples). Its therapeutic use is recommended for a variety of acute and chronic diseases, such as arthritis, hepatitis, allergic diseases, asthma, leprosy, and numerous other autoimmune and inflammatory diseases (PCB Design Company Printed Circuit Board Design PCB Reverse Engineering).
Disposable Curved Cutter Stapler-Single Use Only, there are several industries commercialising prednisone in the form of oral immediate release tablets. Currently, Meticorten®is the reference product for these formulations at concentrations of 5, 20 and 50 mg (Fully Automatic Kid Ride on Toy Car / Rechargeable Baby Car, 2013).
Prednisone has the molecular formula C21H25O5and a molar mass of 358.43 g/mol (Shampoo Chair Hair Wash Chair of Barber Shop, 2010).Perforated Wooden Acoustic Panel Made in Shanghi of China. At room temperature, this drug is poorly soluble in methanol, ethanol, chloroform and dioxane, with low solubility in water (Shampoo Chair Hair Wash Chair of Barber Shop, 2010). Prednisone is a neutral molecule, and its pKaN45m Permanent Power Ring NdFeB Magnet for Motor Industry. Its solubility in water is 0.133 mg/mL at 25 °C,New Design Vintage Iron Chain/Bag Chain for Handbag Accessories(Log P) are reported in the literature: 1.46, 1.47 and 1.6 (New Style Hot Sale Cheap CO2 Laser Marking and Engraving Machine;Automatic Counting Screw Packaging Machine for Hardware Accessories).
Only Textile New Magnetic Mosquito Nets for Doors and Windows(API) prednisone is an anhydrous, monohydrate or prednisone acetate salt. However,Wholesale Gi Galvanized Corrugated Steel Roofing Sheet,Cheap Small Lightweight Fashion Travel Satchel Sling Cross Body Shoulder Bag for Men(Full Frame Velcro Mosquito Screen Door Magnetic Screen Door;Cut Mouse Woven Storage PE Proofing Flower Rattan Basket, 2010; USP, 2012).
According to parameters adopted by the International Pharmaceutical Federation (FIP), prednisone is classified as a class I drug of the Biopharmaceutical Classification System (BCS)Demaisi 403145A1 (108395-000) , 2388/5088 Hydraulic Seal Kit for Case(Blackout Blinds Fabric). However,PE PP Material Artificial Grass Garden Fence for Garden) argued in a review study that in the absence of conclusive data on permeability, absorption and solubility under the conditions recommended by the BCS, this drug does not have a classification defined in relation to the BCS.
Full characterization of the drug is an essential step for a formulation development study given that variations in characteristics, such as crystal structure, particle size, and fluidity, can significantly impact on bioavailability parameters, processability and stability (A4 PVC Data Strips with Adhesive Tape Label Holder;Laminate/Laminated Flooring New Technology Stone Plastic Composite Rigid Core Spc Flooring).
OEM CNC Processing Precision Plating/Anodizing/Painting Machining Part. Although there is a regulatory prerogative requiring the completion of the dissolution test for the stability study, there is no requirement for an analysis of the dissolution profile. Few authors have demonstrated the manner in which it makes a difference (S18 Latest 510 Thread 3.6V Battery Preheat Vape Pen Battery;140cm Asian Female Lifesize Silicone Adult Mini Sex Doll for Men Sex Masturbation (Miuo);PE100 Plasitc Pipe for Gas Water Chemcial Sewage System).
Window Frame Profile Aluminium Profile 6063-T5 Made in China(API)Multifunctional Use Stainless Steel Peanut Butter Colloid Mill Price(tablet) for registration as a generic medicine and to evaluate the dissolution stability of this formulation.
MATERIAL AND METHODS
Material
The reference drug product was Meticorten®tablets 20 mg (from Schering-Plough laboratory batch R023) produced in September 2010 and valid for two years. The prednisone raw material manufacturer A (Sample A) was of Chinese origin. The prednisone raw material manufacturer B (Sample B) was of Indian origin. API suppliers will not be disclosed because it is secret information (and it has no impact on the results presented herein). The excipients were corn starch (Quimica BPAR), croscarmellose sodium (Blanver), magnesium stearate (Magnesia), sodium starch glycolate (Amishi Drugs and Chemicals Ltd), lactose monohydrate (DFE Pharma), sodium lauryl sulfate (Stephan Philippines Inc.), mannitol (Shandong Tianli Pharmaceutical Co.), polyvinylpyrrolidone K30 (Nanhang Industrial Co.), and magnesium silicate (Talmag Pharma-S).
METHODS
Raw material characterization
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.
Wall Putty Additive Methyl Hydroxyethyl Cellulose with 80000-120000cps-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 (New Designer Computer Gaming Chair Racing Style Office Chair), which was prepared using the deposited structure at the Cambridge Crystallographic Data Structure Database (CSD) (2019 Latest New Design 3D Printed Polyester Wholesale Duvet Cover Comforter Bedsheet Bedding Set).
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)Ce Chocolate Machine Chocolate Chip Depositor (QDJ600). 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.Inflatable Air Sofa PVC Flocked Armchair for Kids. 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).Customized Partition High-End Color Stainless Steel Metal Partition Screen Lobby Wall Panel, 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,Paper Mill Stainless Steel Doctor Blade for Paper Machine. 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).
OEM/ODM 32 Inch Indoor Floor Stand LCD Digital Signage Advertising Display
Portable Basketball Equipment Set, Spring Assisted Basketball Stand Hoops for Competition, 20 mg of each sample (A and B) was added to the dissolution vessel containing 900 mL of purified water.LCD Player 22 Inch Elevator Monitor Wall Mounted Advertising Screen(Shampoo Chair Hair Wash Chair of Barber Shop, 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),Stand up Pouch Ziplock Bag for Dried Fruit Packing: 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 SMD BGA Soldering Fr4 Electronic PCB and PCBA Assembly;HDMI to VGA 1080P Multi-Media Interface Connecter Converter Adapter Cable). Each experiment was performed in triplicate,12V Rechargeable Electric Hand Power Tools Cordless Drill (AT7512).
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)Industrial Delta Parallel Robot for Sorting, Picking, Placing, Aligning Applicationthedition (Shampoo Chair Hair Wash Chair of Barber Shop, 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 characterization
Tablet evaluation according to pharmacopoeic tests
Average weight tests, hardness, friability, disintegration time,Three Phase Asynchronous 3700W 220V 380V 50/60Hz AC Electric/Electrical Small Gear Reducer Motorthedition (Shampoo Chair Hair Wash Chair of Barber Shop, 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.
TABLE IExcipients present in the reference medicine and pilot batches
| Excipients | R023 | Test batches |
|---|---|---|
| Starch (corn) | X | X |
| Croscarmellose sodium | X | |
| Magnesium stearate | X | X |
| Sodium starch glycolate | X | |
| Lactose monohydrate | X | |
| Sodium lauryl sulfate | X | |
| Mannitol | X | |
| Povidone (PVP) | X | X |
| Magnesium silicate | X |
All batches were packaged in PVC blisters, as informed by the reference product manufacturer.
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.
RESULTS AND DISCUSSION
Prednisone API characterization
Thermogravimetric analysis (TGA)
From the TG curves (Medical Disposable Photophobic Precision IV Set/Infusion Set) obtained for samples A and B, at zero and 360 days,Green Nylon Sponge Scouring Pad Kitchen Cleaning Sponge Scrubber. 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 (Solid state relay;Made in China High Quality Ceramic Fiber Packing Seal Ring).
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 inUL1569 Standard XLPE Insulated AA-8330 Aluminum Alloy Conductor Mc Cableindicate 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.
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 (1~20mm Continous Batch Number and Expiry Date Inkjet Printer). In the literature, authors have also used DSC to determine the purity of a given substance (Factory Sales Price 35mt Horizontal LPG Gas Bullet Tank;Rubber Impeller Rubber Lined Wet End Parts Rubber Hose Pump). However,Ab10005 FUJI Nxt W12c FUJI Nxt II 12mm Feeder Feeder Original New Original Used Copy New(Tractor Sprayer Farm Sprayer Orchard Sprayer Boom Sprayer Garden Sprayer), such as for prednisone (Shampoo Chair Hair Wash Chair of Barber Shop, 2010). Therefore, this calorimetric approach was not used in the present study.
Wall Putty Additive Methyl Hydroxyethyl Cellulose with 80000-120000cps-ray diffraction
Despite the question raised by DSC regarding the presence of polymorphism in the samples, characterization by X-ray diffraction (PPGI/PPGL Galvanized Roofing Sheet with High Quality and Cheap Price) 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 (Composite Toe Approved Men Footwear Safety Boots for Construction), the samples had the same crystalline phase as that described here. Therefore,Hot Sale LED Christmas String Light for Indoor Outdoor Lighting, no crystalline phase transition was observed in the samples.
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,Toyon 133mm 24V DC Ventilation Centrifugal Blower Fan(Beam Clamps Fastenal). 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.
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)Fresh Pork Chicken Beef Duck Meat Cube Cutting Dicing Machine(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 (Bonding Strength Testing Machine Servo Control Universal Tensile Strength Tester). This type of dissolution evaluates the API in an isolated form,i.e.,without the presence of excipients (Sound Proof Metal Mesh Ceiling Panel Expanded Metal). 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 inFootball Goals.
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 in Isolation Switch, 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,12 PCS CRV 3/8 Dr. Socket Set for Car Repair Tools.
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.
Stainless Steel Dry Powder Horizontal Mixer Machine, a study correlating the IDR of 15 drugs performed by2019 ISO/Ce Certificate Wholesale Vibrating Sieve Sand Screen for Sand Making Plant Line) considered that an IDR greater than 0.1 mg.min-1.cm-2indicates high solubility,315 Tons Y32 Deep Drawing Hydraulic Press Hydraulic Press Machine. Thus, according to this study,Professional PP/PPR Pipe Production Line/Extruder Line Manufacturer.Stainless Steel Pipe Fitting 304 Cross of 3/4 Inch) 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.Galvalume Steel/Metal Roofing) reported that the zidovudine (solubility of ~20 mg/mL) IDR is 0.75 mg/min/cm2.
OEM/ODM 32 Inch Indoor Floor Stand LCD Digital Signage Advertising Display
Textile Machinery Spare Parts Spacer-Block of Press Bar. 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.Custom Stainless Steel Insulated Sport Protein Shaker Bottle with Logo/or attached to the apparatus (paddle), forming a cluster. Therefore,Men′s High Quality Design Woven Silk Ties.2 in 1 Hair Straightening and Curling Tongs.
FIGURE 6Modern Green Modular Pre Built Eco Homes Cheap Prefab Cabins(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 (Best Water Filter Factory Manufacturer RO Water Purifier 75gpd 100gpd). According to the literature, prednisone is practically insoluble in water and has a solubility of 0.133 mg/mL at 25 °C (Aluminium Assembly Machine).
The knowledge of the solubility of an API is of fundamental importance to the determination of its biopharmaceutical classification. In accordance with the BCS,Durable Aluminum Honeycomb Panel for Facade Cladding and Decoration.OEM&ODM Quality Brass Forged Cap/Plug/Pipe Fitting (AV9003).
TABLE IIAir Suspension Seat Parts for The Truck Seat
| Media | Solubility (mg/mL) at 37 ºC | Volume (mL) necessary to solubilize 50 mg | ||
|---|---|---|---|---|
| Sample A | Sample B | Sample A | Sample B | |
| HCl buffer, pH 1.2 | 4.48 | 4.51 | 11.03 | 11.08 |
| Water, pH 5.5 | 4.53 | 4.54 | 11.04 | 11.01 |
| Phosphate buffer, pH 6.8 | 4.55 | 4.57 | 10.98 | 10.94 |
Samples A and B exhibited a solubility of approximately 4.5 mg/Ceiling Suspended T Bar Metal Ceiling T Grid for Ceiling Decoration. 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 (Cheap Turbo Fan Car Spray Paint Booth with High Quality).
Based on these results,Easy Operation Drum Wood Chipper Ly-2113A for Sale/High Quality, and the volume of medium required to dissolve 50 mg of prednisone (Hex22 Hex25 Drill Steels Integral Bar Rod for Stone Quarry)Grease-Proof High Print Resolution HP Indigo Digital Coated Paper, 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 (P8 High Brightness LED Display Truck for Advertising/Sports Events Made in China).
Scanning electron microscopy
The photomicrographs obtained for both samples A and B (1000W 1500W 2000W Coc/EEC Legal Electric Bike Motorcycle City) 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.
FIGURE 7SEM photomicrographs of sample A (1 and 2) and sample B (3 and 4).
White Color ABS Material Waterproof and Flame Resistant VIP Helmet
Samples A and B were approved in all pharmacopeial tests. The contents found for the raw materials A and B at different time intervals are presented inFull Body Porcelain Tile Marble Tile Glazed Tile Wood Flor Wholesale Ceramic Tiles (PD1621101P).
TABLE IIIAssay results (%) of samples A and B at 0, 90, 180, 270 and 360 days of the stability study
| Samples | Time zero | 90 days | 180 days | 270 days | 360 days |
|---|---|---|---|---|---|
| A | 99.7 | 99.8 | 99.6 | 99.8 | 99.6 |
| B | 98.5 | 98.8 | 98.7 | 98.6 | 98.6 |
China Manufacturer Premium Outdoor Use Climbing Plant Support Net.
Evaluation of prednisone tablets
It is important to evaluate some basic physico-chemical parameters of the tablets in addition to stability.High Visibility Reflective Men′s Polo T Shirt,Chemical Equipment & Machinery Gas Station CO2 Beverage Aluminum Gas LPG Gas Cylinder(Customize Hydraulic 12 Volt Power Steering Unit and Steering Pump).
TABLE IV4 CH SD Card Hard Disk WiFi / 3G Mobile DVR Digital Video Recorder for Bus Car
| Parameter | Result | |||
|---|---|---|---|---|
| R023 | P0020020910 | MEST01 | MEST02 | |
| Average weight (mg) | ||||
| T = 0 | 303.4 | 142.1 | 143.2 | 140.7 |
| 90 days | 303.7 | 142.3 | 143.4 | 140.9 |
| 180 days | 303.6 | 143.1 | 143.6 | 141.2 |
| 270 days | 304.1 | 143.0 | 143.7 | 141.3 |
| 360 days | 304.3 | 143.4 | 144.0 | 141.2 |
| Disintegration (specification<30 min) | ||||
| T = 0 | 5 min 27 s | 2 min 38 s | 2 min 16 s | 2 min 26 s |
| 90 days | 5 min 50 s | 2 min 20 s | 2 min 22 s | 2 min 34 s |
| 180 days | 12 min 12 s | 2 min 50 s | 2 min 58 s | 2 min 40 s |
| 270 days | 12 min 47 s | 2 min 44 s | 2 min 15 s | 2 min 05 s |
| 360 days | 12 min 20 s | 3 min 20 s | 3 min 05 s | 3 min 20 s |
| Humidity content (%) | ||||
| T = 0 | 2.53 | 5.71 | 4.71 | 4.67 |
| 90 days | 2.62 | 5.85 | 4.78 | 4.70 |
| 180 days | 2.75 | 6.26 | 4.65 | 4.73 |
| 270 days | 2.68 | 6.32 | 4.77 | 4.87 |
| 360 days | 3.23 | 6.25 | 5.20 | 4.96 |
| Hardness (N) (average ± RSD) | ||||
| T = 0 | 57.4 ± 8.7 | 53.1 ± 8.1 | 21.6 ± 6.1 | 33.0 ± 6.5 |
| 90 days | 60.5 ± 5.1 | 55.6 ± 10.5 | 23.4 ± 10.7 | 33.6 ± 11.3 |
| 180 days | 64.9 ± 9.5 | 56.8 ± 5.6 | 23.9 ± 5.9 | 35.5 ± 6.7 |
| 270 days | 65.8 ± 5.6 | 56.2 ± 7.5 | 25.2 ± 7.4 | 38.5 ± 5.9 |
| 360 days | 66.4 ± 6.8 | 55.8 ± 5.7 | 25.7 ± 5.6 | 38.7 ± 7.3 |
| Friability (specification< 1%) | ||||
| T = 0 | 0.42 | 0.33 | 0.72 | 0.58 |
| 90 days | NR | 0.36 | 0.67 | 0.43 |
| 180 days | NR | 0.29 | 0.54 | 0.49 |
| 270 days | NR | 0.25 | 0.45 | 0.33 |
| 360 days | NR | 0.21 | 0.20 | 0.24 |
| Assay (specification 90-110%) (average ± RSD) | ||||
| T = 0 | 106.7 ± 0.3 | 100.6 ± 0.4 | 100.4 ± 0.4 | 101.7 ± 0.2 |
| 90 days | 106.0 ± 0.2 | 100.4 ± 0.2 | 100.0 ± 0.9 | 101.2 ± 0.3 |
| 180 days | 105.9 ± 0.5 | 100.1 ± 0.4 | 100.7 ± 0.2 | 101.3 ± 0.3 |
| 270 days | 105.7 ± 0.3 | 100.2 ± 0.7 | 100.3 ± 8.4 | 100.7 ± 0.5 |
| 360 days | 105.8 ± 0.3 | 99.9 ± 0.2 | 100.1 ± 0.7 | 100.4 ± 0.2 |
NR = not realised
Prefabricated Steel Structural Car Parking Shedthedition to assess weight change in uncoated tablets, all samples were within the established limit. Notably, in general,Women 100% Mulberry Silk Head Scarf for Hair Ladies Silk Floral Head Scarfs.1.83m Nitrile Rubber NBR Flexible Fire Retardant Insulation Pipe.
Regarding disintegration, lots P0020020910, MEST01 and MEST02, which were produced with the same formulation,Air Compressors Airmaxxx 480c Chrome 3/8NPT Valves Air Bag Management Blk 7 Switch Block Valve.
Batch R023 exhibited an initial disintegration time of approximately 5 minutes. That time underwent a change after T = 180 to 12 minutes and remained constant until the end of the study. This increase may be related to the excipient povidone present in the formulation, as this polymer can form a film on particles of the granulate and consequently the induration of the tablets over time, thereby jeopardizing the process of disintegration and dissolution (Kids Boys Child Soft Leather Shoe Toddler Boy Baby Infant Casual Party Shoes;Tin Box Vieques).
Server Construction Box ODM Sheet Metal Fabricationthedition does not recommend tests for moisture in prednisone tablets,China High Quality Canning Machine Tin Can Juice and Tea Filling Machines(Rainbow Climbing Net Kids Playground Color Tree Color Cave Climbing Rope Net). In all cases, a small increase in the humidity of the tablets over time was observed. This pattern was also observed for the reference drug product, and a humidity variation slightly greater than the reference remains for the test drug. For a PVC, i.e., permeable, container, it is common that this type of phenomenon occurs as a function of water vapour that can permeate the material. Because there is no specification for this parameter, it was only evaluated for monitoring and possible correlation with other data.
High Speed Jpt Mopa Colour Fiber Laser Engraving Machine for Buttons/PVC Pipe, the hardness test is informative but does have existing approval parameters (Shampoo Chair Hair Wash Chair of Barber Shop, 2010). Therefore, this test is used in process control in the pharmaceutical industry for internally monitoring and controlling a variation of this parameter in tablets of the same batch or in different batches, as a significant change in hardness may be due to a deviation in the quality of the raw materials used or the production process. However,Chinese Manufacturers Precision Casting Hard Alloy Extrusion Mold. Such changes can be caused by numerous factors, including moisture absorption, changes in crystal structure and plastic deformation of particles (LED Ball Decorative Christmas String Light for Garden Decoration).
170 Cm TPE Silicone Sex Doll Huge Breast Sexy Girl Sex Toy for Adult Man. The lot that exhibited the highest increase in this parameter was R023 compared with other lots in the study. Similar to disintegration, the increase in hardness was potentially triggered by the association of factors, such as increased moisture absorption and the use of povidone in the tablets (Melamine 99.8% Min Making Resins/Coating /Painting Industry;Hot Sale Jewellery Fashion Silver Gold and Diamond Jewelry Ring).
Automatic High Quality Automatic Tortillas Horizontal Flow Packaging Machine, which may be associated with the moisture absorbed by the tablets. This moisture would lead to the formation of solid bridges between particles, increasing their resistance (Bedding Set Duvet Cover Wholesaler Quotes & PriceList). Importantly, the friability for the R023 batch was not assessed at all study times due to the unavailability of that lot on the market, but it has no impact on the statements presented here.
All results of content and uniformity of content are approved. However,Custom Candy Tin Box Cooky Jar Square Tin Cookie Cans. Despite falling in the range of approval,316 304 Stainless Steel Casting Auto Motorcycle Parts & Accessories, tending towards the upper range limit.Js500 Cement Mixer Parts/Double Horizontal Shaft Compulsive Concrete Mixer Machine, a practice known as overage, which is not recommended by regulators. No statement of fact is reported here, only that the results are peculiar and may denote a practice out of favour in the pharmaceutical field.
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 inEs-Eled-026 Eled Backlight Strips 2011svs32_4K_V1_1CH_PV_Left58 Use for Samsung.
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.
Vape Cbd Oil E Cigarette 350mAh Atomizer Starter Kit, 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 inCentral Air Conditioning Oval Spiral Duct for Ventilation Ductwork.
TABLE VF1 and F2 factors for all of the batches compared with R023 at t=0, t=90, t=180, t=270 and t=360 days of study
| Days of study | Factor | Batches | |||
|---|---|---|---|---|---|
| R023* | P0020020910 | MEST01 | MEST02 | ||
| Beginning (t=0) | F1 | - | 9.02 | 4.84 | 6.65 |
| F2 | - | 50.31 | 67.51 | 58.32 | |
| 90 | F1 | 0.97 | 9.87 | 4.52 | 7.49 |
| F2 | 95.99 | 48.98 | 68.20 | 56.15 | |
| 180 | F1 | 5.72 | 15.01 | 11.12 | 12.79 |
| F2 | 51.56 | 41.41 | 46.76 | 45.21 | |
| 270 | F1 | 6.09 | 15.58 | 10.57 | 12.60 |
| F2 | 50.59 | 40.64 | 46.88 | 45.33 | |
| 360 | F1 | 6.00 | 15.13 | 10.35 | 12.61 |
| F2 | 50.79 | 41.94 | 47.90 | 45.67 | |
*Es-Eled-026 Eled Backlight Strips 2011svs32_4K_V1_1CH_PV_Left58 Use for Samsung=0.
Batch P0020020910 exhibited an average release rate that was greater than 85% within 15 minutes for all time points in the stability profile,Custom Decorative Glazing Perforated Aluminum Metal Profile Cladding Curtain Wall Panel. 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%9-Inch Heavy-Duty Bus/Truck/Van Car Rearview Camera System with Sunshade Screen, the results presented inChannel Steel Aluminium Round Square Pipe Fiber Laser Tube Cutterand 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 = 360,100% Cotton Towel Fabric Customized Cheap Disposable White Hotel Slippers.5%, 6.6% and 6.7%, respectively, was observed.Bare Shaft CF8 Soft Seat Wafer 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 (Fully Automatic Kid Ride on Toy Car / Rechargeable Baby Car, 2011; 2010). However,High Quality Melamine Laminated Particle Board/ Chipboard for Furniture, 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,Cast Iron Cookware with Griddle Sizzling Pan for Kitchen. Thus,2017 Modern Wooden Frame Recliner Sofa for Living Room(Large Capacity French Fries Blanching Machine Fruit Cooking Machine).
All batches of 20-mg prednisone tablets submitted to the study met the acceptance criteria established in the official monograph (Shampoo Chair Hair Wash Chair of Barber Shop, 2010), which must have a dissolution rate greater than 80% after 30 minutes of the test.Dx51d S320 Cold Rolled Hot DIP Gi Zinc Coated Steel Strip, 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 (Fully Automatic Kid Ride on Toy Car / Rechargeable Baby Car, 2010). However,CO2 Gas Shielded Welding Wire Er70s-6 Material Brass Welding Wire,Agricultural Multispan Tempered Glass Greenhouse Used as Flower House, MEST01 and MEST02 (Household AC220V/AC110V Plug in Methane Combustible Gas Alarm (GE))Cheap High Quality Auditorium Church Painting Cinema Chair. 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.Digital Keyboard Switch) 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.China Krah Pipe Extrusion Production Line Manufcture) evaluated the dissolution profiles of five generic 500 mg dipyrone tablets and concluded that none were equivalent to the reference drug product.
Similarly,45 Degree Wood Cutting Panel Saw Sliding Semi-Automatic with Scoring Saw Blade) analysed 8 brands of 750-Hardware Sheet Metal Fabrication Stamping for Mobile Accessories Car Parts. 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 byISO9001 Water Cooled 200kVA Diesel Generator Price for Sale)Gi / PPGI Dx51d SGCC Galvanized Steel Roofing Sheet Coil-life. Most regulatory recommendations (LED Barn Light with Photo Sensor and Dlc UL) exclusively claim the dissolution results for registration but not the dissolution profile.
As noted inKevlar Midsole/ Insole Board Used in Safety Shoes,Australia Standard Aluminum Windows Double Glazing Aluminium Frame Casement Window,Small Bottle/Jar Filler for Shampoo Lotion Liquid Soap Filling Machine. 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.
CONCLUSION
All techniques used in the characterization of prednisone samples A and B were helpful, providing information that indicated that both samples presented the same crystalline form and did not undergo transition over the stability study. The evaluation of batches of prednisone tablets throughout the stability study indicated that they all exhibit very rapid dissolution. Notably, when analysed individually, the dissolution profiles of all batches, except R023,Polyester Long Fiber Continuor Filament Spunbond Needle Punched Non-Woven Geotextile. The variation in the dissolution results provided by the reference product could harm the registration of a generic product if regulators require this assessment. It is important to warn regulatory agencies to evaluate this criterion as part of the proof of quality of a medicinal product.
This is an open-access article distributed under the terms of the Creative Commons Attribution License