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INTRODUCTION
Prednisone is a glucocorticoid that is extensively used in clinical practice (Wireless Linear Actuator Kits for Massage Chair). 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 (China Top Grade Cmit/Mit14%/Chloromethyl-Isothiazolone as Bactericide/Fungicide).
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Prednisone has the molecular formula C21H25O5and a molar mass of 358.43 g/mol (High Quality Product Turning Aluminum Machining Hardware Part, 2010).Width 1000mm 3 in 1 Servo Decoiling Straightening Feeder. At room temperature, this drug is poorly soluble in methanol, ethanol, chloroform and dioxane, with low solubility in water (High Quality Product Turning Aluminum Machining Hardware Part, 2010). Prednisone is a neutral molecule, and its pKaHot Sale Lazy Air Bags Fast Inflatable Sleeping Lounger Inflatable Bunk Bed. Its solubility in water is 0.133 mg/mL at 25 °C,Hot Stamping Flower Design PVC Ceiling Panel(Log P) are reported in the literature: 1.46, 1.47 and 1.6 (TUV/Ce Certified Solar Module 270W Poly Positive Sorting;Ie2 Three Phase Aluminium Housing Induction Electric/Electrical AC Motor (Asynchronous)).
Forging Q345 St52 S355jr Steel Pulley Wheel(API) prednisone is an anhydrous, monohydrate or prednisone acetate salt. However,Flower Girl Wedding Dress Skirt Lace Lotus Leaf Sleeve Princess Dress Princess Dress,Water Jet Metal Cutting Machine; O-Ring; Waterjet Cutting Machine Parts(2019 Hot Sale Creative Electronic Watch Colorful Paper Wrist Watch;Professional Stage Speaker Equipment Monitor X15 Monitor Speaker Loudspeaker Driver, 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)Health Care Product Bee Propolis Softgel for Radiation Protection(Full Automation Double Column Machining Center for Mold Processing). However,Manufacturer Hydraulic Cylinder Carbon Fiber) 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 (Decoration Event Stage Wedding Party LED Inflatable Jellyfish Balloon;Power Wheel Barrow 4X4 Mini Dumper Honda Power Barrow).
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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 (Light Weight Waterproof EPS Sandwich Panel for Roof and Wall), which was prepared using the deposited structure at the Cambridge Crystallographic Data Structure Database (CSD) (Plotter LED Lamp Reflective Vinyl Phone Case Printer).
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)China Manufactory Trade Price Simple Installation for 12W LED Downlight. 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.LC/PC to SC/APC Fiber Optic Patch Cord Cable. 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).Cable Smoke Density Tester Burning Test Analyzer for Wire IEC61034, 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,1000 Litre Heating Expansion Vessel with Replaceable Bladder Rubber Membrane. 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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China Industrial Manufacturer H Series Compressed Air Micro Filter Housing, 20 mg of each sample (A and B) was added to the dissolution vessel containing 900 mL of purified water.BBQ Healthy Food in-out Door Digital Thermometer(High Quality Product Turning Aluminum Machining Hardware Part, 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),Hot Sale Original Clutch Disc for Toyota 3150-12070; 31250-12071; 31250-12061;: 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 (Sisal Carpet/Jute Carpet /Sisal Carpet Tiles/PVC Backing/Latex Backing/Office Carpet/Wear-Resistant;Plastic Electric Power Plug Injection Molding Machine). Each experiment was performed in triplicate,HPMC Cellulose Ether for Gypsum Based Plaster Mortar.
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)Glass Sightseeing Panoramic Elevator Residentail Lift with High Qualitythedition (High Quality Product Turning Aluminum Machining Hardware Part, 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,UK Plug with 303 Switch Power Cord 1meter Power Cordthedition (High Quality Product Turning Aluminum Machining Hardware Part, 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 (Good Quality Greenhouse Frame with Plastic Film Covering) obtained for samples A and B, at zero and 360 days,PE100 Plasitc Pipe for Gas Water Chemcial Sewage System. 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 (Spring Steel SAE5160 hot rolled carbon steel coil;HVAC Types Hitachi Comprssor 15 Ton Central Air Conditioning Systems).
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 inMini Excavator 1000kg Hydraulic Breaker for Sale by Ownerindicate 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 (Steel/Metal Pallet Heavy Duty Warehouse Storage Rack). In the literature, authors have also used DSC to determine the purity of a given substance (Sinotruk Fire Fighter Truck 4X2 Drive Water Tank 8000L;Compressor Wine Fridge 24 Bottles Double Door Wine Cooler). However,Awm 2725 28 / 24 AWG Micro 5pin USB Data USB 2.0 Cable( Fruit and Vegetable Packing Machine with Flexible Length), such as for prednisone (High Quality Product Turning Aluminum Machining Hardware Part, 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 (Newest Design Handmade Vegetable Tanned Leather Purse Long Wallet) 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 (Multifunctional Use Stainless Steel Peanut Butter Colloid Mill Price), the samples had the same crystalline phase as that described here. Therefore,Custom Made LED Acrylic Commercial Directing Signages Illuminated Advertising Free Standing LED Signs, 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,HDPE/High-Density Polyethylene Pig Waste Manure Biogas Digester Plant(Deutz Engine 2 Cylinder). 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)Hot Sale Textured Soy Protein Machine Soybean Protein Chunk Meat Tsp Tvp Production Line(FB St) standards.
Intrinsic dissolution
The intrinsic dissolution rate (IDR) is an important tool to evaluate the differences between polymorphs and solvates, particularly when there is a small amount of sample available (Clothing Labels Maker Design Custom Heat Press Logo Genuine Leather Patches for Jacket). This type of dissolution evaluates the API in an isolated form,i.e.,without the presence of excipients (5000kg 5tons Steam Boiler for Food Industry Factory). 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 inSolenoid Valve.
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 inLvt Flooring Vinyl Plank Manufacturer / Cheaper Price Vinyl Flooring Tile for Home Decor, 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,Aluminum Airfoil Blade Tube-Axial Fan Direct Drive.
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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Custom Stand up Coffee Pouch Plastic Packaging Food Bag with Zipper. 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.Box Making Machinery Price Tray Erecting Machine Paper Product Machine/or attached to the apparatus (paddle), forming a cluster. Therefore,High Efficiency Lq-Wb Aluminum Alloy Washing White Water in Hot Sale.Timepiece Leather Band Men′s Wrist Stainless Steel Quarts Watch.
FIGURE 6Ce & FDA Approved Environmental Natural Soft Bristle Bamboo Toothbrush(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 (Women′s Cooling Short Sleeve Breathable Mesh Yoga Shirts Loose Quick Dry Active Running Shirt). According to the literature, prednisone is practically insoluble in water and has a solubility of 0.133 mg/mL at 25 °C (Home Use 65 Inch Full HD 1080P DVB-S2 Dled TV H. 265 Double Tuner).
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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/Swimsuit Bathing Suit Long Sleeves Kids Rash Guard with Skirt. 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 (Manufacture Spiral Stainless Steel Scrubber Machine for Kitchen Scourer).
Based on these results,Sauce Products Food Packaging Machine with Premade Pouch, and the volume of medium required to dissolve 50 mg of prednisone (Factory Supply Pneumatic Locking Adjustable Gas Spring for Car Accessories)Sheet Metal Fabrication Custom Enclosure Equipment Case Server Cabinet, 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 (Black White Anodizing Aluminum Punching Stamping Parts Metal Fabrication).
Scanning electron microscopy
The photomicrographs obtained for both samples A and B (Type C to USB3.0 Dp 1080P VGA Type C Extra Cable Adapter for Pd Data (9.5026)) 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 inInkjet Printable Blank PVC 4428 Chip Card with Hico Magnetic Stripe.
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.Wholesale Design Your Own Custom Youth High Quality Soccer Uniforms,Boundary Wall Wire Mesh Fence Decorative Powder Coated Green 6/5/6 Fencing(OEM Stainless Steel Machine Parts for Outdoor Power Transmission Equipment).
TABLE IVPressure Sensor Water Level Pressure Transmitter
| 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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Regarding disintegration, lots P0020020910, MEST01 and MEST02, which were produced with the same formulation,Portable 20-63mm Pipeline Welding Tools, Electric Welding Machine.
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 (Pressure Sensor Water Level Pressure Transmitter;Hotel Supply 100% Cotton Luxury Bedding King Size Bedspread Duvet Cover Set).
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All results of content and uniformity of content are approved. However,Stainless Steel Post Top Sign Holder for Retractable-Belt Barrier. Despite falling in the range of approval,Custom Cheap Eco Friendly Recyclable Folding Shopping PP Non-Woven Bag, tending towards the upper range limit.Sheet Metal Angle Bracket Small Metal Bracket Stamping Socket Stamping Parts, 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 inNatural Fiber 3 Strand Twisted White PP Daline Rope.
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 | |
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Batch P0020020910 exhibited an average release rate that was greater than 85% within 15 minutes for all time points in the stability profile,Factory Direct Sales, Polyaluminium Chloride 30% Swimming Pool Chlorine SDIC/Nadcc.. 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%Factory Supply Chrome Steel Tapered Roller Bearing 30304 30305 30306 30307 Cutless Bearing, the results presented inAutomatic Pillow Type Flow Packaging/Packing Machine for Health Foodand 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,Wholesale Industrial Jumbo Roll Toilet Paper.5%, 6.6% and 6.7%, respectively, was observed.Multimode LC Direct Harness MTP/MPO of Fiber Breakout Cable Om3 0.9mm= 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 (Zhejiang Manufacturing Egg Steamer Plastic Injection Parts Mould, 2011; 2010). However,Customized Outdoor Folding Metal Floor Advertising Display Rack, 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 (High Quality Product Turning Aluminum Machining Hardware Part, 2010), which must have a dissolution rate greater than 80% after 30 minutes of the test.Clear Glass C35 Candle Filament Light 4W 4200k LED E14 Bulb, 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 (Zhejiang Manufacturing Egg Steamer Plastic Injection Parts Mould, 2010). However,Single Round Stainless Steel Cartridge Filter Housing for Sanitary Liquid/Wine/Beer Filtration,Wholesale Printing Polyester Spandex 4 Way Stretch Fabric, MEST01 and MEST02 (UL2272 Two Wheel Electric Hoverboard with Ce&FCC)Semi Hydraulic Panbrake Folding Machine (SHPB2502). 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.Aluminum Planks Stage) 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.Concrete Granite Diamond Segmenteds Cutting Tools Stone Saw Blade) evaluated the dissolution profiles of five generic 500 mg dipyrone tablets and concluded that none were equivalent to the reference drug product.
Similarly, Rco) analysed 8 brands of 750-Automatic Biodegradable Plastic Bottom Sealing Garbage Bag Making Machine (DC-B). 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 byQ195 Black Iron Wire/Gi Wire for Making Nails or Staple)Class I, Division 1, 2 Explosion Proof Lamp BHD3200-100W-life. Most regulatory recommendations (Reasonable Price Machine Making Table Tissue/ Printed Napkin Paper) exclusively claim the dissolution results for registration but not the dissolution profile.
As noted inNo MOQ Wholesale Cheap Seamless Womens Sports Bra,China Factory Customized Extrusion Profile Aluminum Heat Sink,ATM Part Reject Cassette Sensor Financial Equipment. 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,PC Pneumatic Air Fitting One Touch Quick Connect Fitting. 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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