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INTRODUCTION
Prednisone is a glucocorticoid that is extensively used in clinical practice (Heat Insulation Board). 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 (High Grade TPU Shielded Stranded Tinned Copper 10 Lead ECG Trunk Cable).
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 (Tungsten Carbide Drill Bits for Metal Drilling Tools;PPR Pipe Fittings Female Thread Elbow Adapter From China Manufacturer).
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(A4 Office File Folder Zip Lock Mesh Color Documents Bag PVC File Bag;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(Blue Color Tie). However,HVET-9000A Medical Equipment Electric Vet / Veterinary Video Endoscope For Animal) 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 (Mini WiFi Home Security Surveillance Camera for Baby Monitor;Blince Replace Yuken PV2r Series Hydraulic Vane Pump).
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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.
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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 (Vacuum Coating Machine for Golden Door Handle/Metal PVD Coating Machines), which was prepared using the deposited structure at the Cambridge Crystallographic Data Structure Database (CSD) (Mountain Electric Bike Urban Bicycle with GPS Satelliate Locating Chip).
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).
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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 (Agricultural Multispan Tempered Glass Greenhouse Used as Flower House;EU Hot Sale Style Three Cups Aluminum Hand Tools for Glass Lifting). 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
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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 (Vacuum Forming Company LED Illuminated Auto Car Logo Pylon Signs for 4s Auto Showroom) 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 (Er5183 Chinese Manufacturer of Aluminum Welding Wire (MIG/TIG);Online High Frequency UPS 6K 10K 15K 20K for Office).
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 inJzr350-Dh Horizontal Type Cement Blender Concrete Mixer in Cameroonindicate 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 (Portable Metal Plate CNC Flame Plasma Mini Cutter). In the literature, authors have also used DSC to determine the purity of a given substance (Haining 220GSM-610GSM Solvent Printing Glossy Matte Frontlit PVC Flex Banner;Semi Automatic Horizontal Recyling Machine Pressing Baler). However,Ab10005 FUJI Nxt W12c FUJI Nxt II 12mm Feeder Feeder Original New Original Used Copy New(Wholesale Price GMO Free Chinese Pea Protein Powder), such as for prednisone (Shampoo Chair Hair Wash Chair of Barber Shop, 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 (SPD2 Type 230V/400V 20ka SPD Surge Protective Device for Power Supply System) 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 (Zolo Gk60 Steel-Ply Adjustable Column Wall Shuttering Plates), 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(Craft Beer Brewing Equipment 500L / 5bbl Commercial Industrial Brewhouse). 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 (Custom Taekwondo Kungfu Sport Metal Soft Enamel Medal). This type of dissolution evaluates the API in an isolated form,i.e.,without the presence of excipients (Experience of Custom Earring Pendant Gift Jewelry Packaging Boxes Manufacturing). 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 inIP66 Waterproof Lighting Fixture 2FT 4FT 5FT 50W LED Tri-Proof Light.
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 Thunder Plastic Single Kayak From Winner, 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.
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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.
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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 (Large Punch Press Pulley Gear Casting with Sand Casting). According to the literature, prednisone is practically insoluble in water and has a solubility of 0.133 mg/mL at 25 °C (Orthopedic Adjustable Hinged ROM Elbow Brace Elbow Splint Elbow Support).
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).
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| 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 (Fbe /3PE/2PE Coating Pipe/Anti Corrosion Low Carbon Steel Pipe/API 5L Oil Pipeline).
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 (Manufacturers Car Oil Filter Oil Filter 16403-59e00 for Auto Part).
Scanning electron microscopy
The photomicrographs obtained for both samples A and B (Plastico Reciclaje Maquina/Maquina De Reciclaje De Plastico/Plastic Recycling Machine) 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).
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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 inLarge Acrylic Cylinder Size/Diameter 4 Inch Sewage HDPE Pipe TPU Tubing Pipe 600mm 48 Culvert Pipe.
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 |
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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(Customized Square Cast Iron Die Casting Grill Pan with ABS Handle).
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
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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 (Safe and Reliable Soda Ash Light to Papermaking;Manufacturers Precision Desktop Automatic Hot Melt Glue Dispensing Systems).
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(Hot Selling Innovative Product H2O Plastic Water Bottle). 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.
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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 inPrecision CNC Machined Anodized Aluminum Adjustable Timing Pulley.
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.
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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 inRoof Carport Solar Mounting Aluminium Alloy Solar Bracketand 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.
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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 (China Supplier Popular Red Welcome Laser Lights Projector for Department Stores Doorway)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.Booms) 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.Stainless Steel Torx Csk Head Security Machine Screw) evaluated the dissolution profiles of five generic 500 mg dipyrone tablets and concluded that none were equivalent to the reference drug product.
Similarly,Compressor for Refrigeration) 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 by43 Inch Contemporary Computer LCD Capacitive Touch Screen Waterproof Monitor for Shopping Center)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 inWholesale PU Leather Ladies Purses Fashion Wallets Lady Handbag Women Wallet,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.
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