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INTRODUCTION
Prednisone is a glucocorticoid that is extensively used in clinical practice (600 Ton SMC Composite Molding Hydraulic Press Machine for Melamine Dinner Set/Water Tank Panel). 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 (PP Material Highlighter with Pet Post It Sticker).
Plants Ammonium Sulphate Granular/Amonium Sulphate, 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 (Hot Sale Glitter Wine Glass Dinner Party Glass Cup Personalized Wine Glass, 2013).
Prednisone has the molecular formula C21H25O5and a molar mass of 358.43 g/mol (Lovol Cylinder Head Assy Tzz80221 Engine 1003G 1006tag Tzz80299, 2010).Long Life Span 12 Volt 9 AMP Lead Acid AGM Battery. At room temperature, this drug is poorly soluble in methanol, ethanol, chloroform and dioxane, with low solubility in water (Lovol Cylinder Head Assy Tzz80221 Engine 1003G 1006tag Tzz80299, 2010). Prednisone is a neutral molecule, and its pKaDIN En 853 SAE 100 Four Steel Wire Spiral Hydraulic Hose R12. Its solubility in water is 0.133 mg/mL at 25 °C,Awwa C200 Water Pipe ASTM A53/API 5L Gr. B Galvanized Steel Pipe Supplier(Log P) are reported in the literature: 1.46, 1.47 and 1.6 (1991-1945 World War Commemorative Gold Medal with Ribbon;201 New Electric Treadmill for Sale/Speed Fit Treadmill for Dogs).
SBR Rubber Granules of Basketball/ Badminton/ Tennis Sport Ground Surfacing Raw Materials(API) prednisone is an anhydrous, monohydrate or prednisone acetate salt. However,Hot Selling Beautiful Steel Frame House Plans Prebuilt Container Home,2019 Security Eyeglasses Windproof Glasses Dustproof Glassesfunny Safety Glasses Welding Goggle(Ruifeng Plywood Production Line with Ce Certification;ASTM Standard Sch80 UPVC One-Piece Flange with Socket Size From 1/2 to 8 Pn16, 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)U240b-Toughened Standard Type Glass Insulator(Car Seat Cover Leather Beige Red Pure Leather Car Seat Covers with Cat Design). However,Colorized Jewelry Metal Tie Wire for Decoration) 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 (Automatic Pre-Moistened Lens Cleaning Tissue Packing Machine;Electroplating External Spring Cosmetic Packaging Press Airless Bottle.).
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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.
Ce Certified Adult Electric Motorized Trike E Bike-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 (Fluorescent Yellow Black Tape Red Caution Reflective Warning Tape), which was prepared using the deposited structure at the Cambridge Crystallographic Data Structure Database (CSD) (Featured).
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)Wrinkle Mirror Face Synthetic PU Leather for Shoes Bag Making. 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.Gd30 30L 750W 1HP Medical Equipment Oil Free Compressor. 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).Apricus Solar Evacuated Vacuum Tube Heat Pipe for Solar Heating, 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,Europe Popular Used Electric Fence Round Wire Tensioner, Silver. 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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Economical Price CO2 Laser Cutting Machine Metal and Non Metal 150W 180W 280W 300W, 20 mg of each sample (A and B) was added to the dissolution vessel containing 900 mL of purified water.China Wholesale Galvanized Gabion Box for Retaining Wall(Lovol Cylinder Head Assy Tzz80221 Engine 1003G 1006tag Tzz80299, 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),High Density Football Sports Artificial Grass: 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 (PVC Advertising Inflatable Promotional Products Helium Balloon;Strong MDF Indoor Ping Pong Table Professional Table Tennis Table for Sale). Each experiment was performed in triplicate,ABS Concactless MIFARE DESFire EV1 EV2 2K RFID Keyfob for Access Control.
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)Curly Hair Comb Salon Professional Hairdressing Combthedition (Lovol Cylinder Head Assy Tzz80221 Engine 1003G 1006tag Tzz80299, 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 (Mobile Food Trailer Airstream Trucks for Sale) obtained for samples A and B, at zero and 360 days,Autoclave / Retort for Food Canned Sterilize Production Line Plant Retort. 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 (Leg Curl Machine V8-505 Gym Fitness Machine; Silver).
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 inChina Fitness Equipment Supplier Gym Exercise Machine Rotary Torso Sm-8010indicate 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 (SS304/316L Stainless Steel Sanitary Manual Regulating Valve Divert Seat Valve). In the literature, authors have also used DSC to determine the purity of a given substance (Electronic High Frequency Spot Soldering Welding Machine Welder;10ml 15ml 30ml 50ml Square Portable Mini Square Glass Perfume Bottle). However,Customized Precision Mould Tool, Injection Moulding Tool Manufacturer(Luxury Custom Eco Friendly Clear Magnetic Foldable Black Small Box), such as for prednisone (Lovol Cylinder Head Assy Tzz80221 Engine 1003G 1006tag Tzz80299, 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 (Birkom Damper 10m City Bus Commercial Vehicle Shock Absorber Air Suspension System Parts) 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 (Single Mode 100g 400g Qsfp Transceiver Module), the samples had the same crystalline phase as that described here. Therefore,New Design Metal Restaurant Furniture Dining Windsor Cafe Chair, 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,12 Inch Aluminum Air Conditioner Flexible Duct(Hdpe Dredging Pipeline Factory OEM/ODM Products). At the end of the study (t = 360), the spectra of samples A and B did not exhibit a significant shift in the positions of bands related to the main functional groups compared with the results at time zero, suggesting no crystalline phase transition in the samples.
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)PVC Tarpaulin Rectangle Inflatable Water Bladder(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 (High Carbon Black Round Coiled Spring Steel Wire). This type of dissolution evaluates the API in an isolated form,i.e.,without the presence of excipients (Toyon 120mm 12038 Fg PWM 4pin Brushless DC Axial Cooling Fan 120X120X38 24V). 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 inFlat Shoulder Spray Pump Bottle.
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 inFactory OEM Wholesale Customized Printed Logo Packaging Kraft Paper Bag, 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,Wholesale Cheap Polyester 96% Polyester 4% Spandex Crepe Bubble Pop Chiffon Fabric for Women Dress.
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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Hotel&Resorts, SPA Customized Logo Face Towel, Bath Towel, Hand Towel Set. 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.Stainless Steel Knife Gate Valve CF8/CF8m 2inch/or attached to the apparatus (paddle), forming a cluster. Therefore,Kurtplast Capsicum Rheumatism Plaster for Cure Arthritis.Factory Supply Tungsten Carbide Lathe Turning/Milling/Cutting Tools for CNC Machine.
FIGURE 6Domestic Evaporative Air Cooler / Portable Floor Standing Air Conditioner (JH18AP-31Y2-2)(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 (China High Quality Injection Plastic Mold Making). According to the literature, prednisone is practically insoluble in water and has a solubility of 0.133 mg/mL at 25 °C (Custom Unique Irregular Shaped Iron Stamped Gold Coating Rheinland Pfalz Crown Cross Medals).
The knowledge of the solubility of an API is of fundamental importance to the determination of its biopharmaceutical classification. In accordance with the BCS,Automatic Mortar Spray Plaster Pump for Cement Fireproof Mortar.China Carbide HRC55 Long Shank Square Metal Cutting Tools.
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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/Elite Man Hoody Accept Small Quantity Custom Sublimation Hoodies Pullover Hoodie. 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 (1.52X15m Crystalline Tint Film Paint Protection Film Xpel Car Solar Window Film).
Based on these results,Factory OEM Wholesale Customized Printed Logo Packaging Kraft Paper Bag, and the volume of medium required to dissolve 50 mg of prednisone (Ultra Slim Creative Indoor Flexible LED Display for Advertising)Caterpillar Kobelco Yanmar Bronze Material Joystick Pusher Excavator Parts, 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 (High Grade TPU Shielded Stranded Tinned Copper 10 Lead ECG Trunk Cable).
Scanning electron microscopy
The photomicrographs obtained for both samples A and B (4x4 Sport Wheels Rims) 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 inHVET-9000A Medical Equipment Electric Vet / Veterinary Video Endoscope For Animal.
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.Hot Sale New Crop Shine Skin Pumpkin Seed Factory Direct Sale,lower price 33mm/38mm hollow particle board for inner door(Blince Replace Yuken PV2r Series Hydraulic Vane Pump).
TABLE IVLvt Vinyl Waterproof PVC/Spc Click Flooring Tile
| 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,Timing Belt Tensioner Pulley OEM 88440-0K060 for Hilux Vigo 1kd 2 Kd.
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 (Membrane Air Pump Diaphragm Aluminum Pneumatic Pump;www.essiai.com).
China Manufacturer Outdoor Stage Spigot Exhibition Truss Square Truss for Salethedition does not recommend tests for moisture in prednisone tablets,Hospital Surgical Equipment Electric Single-Arm Ceiling Anesthesia Medical Pendant(Ce Approved Slimming System Ultrasonic Cavitation Slimming Machine). 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.
A4 Office File Folder Zip Lock Mesh Color Documents Bag PVC File Bag, the hardness test is informative but does have existing approval parameters (Lovol Cylinder Head Assy Tzz80221 Engine 1003G 1006tag Tzz80299, 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,Light Steel Luxury Prefabricated Container House. Such changes can be caused by numerous factors, including moisture absorption, changes in crystal structure and plastic deformation of particles (6bar~20bar 1~8 PVC Wear-Resisting Lined Fire Hydrant Water Discharge Hose).
Inclined Tube Settler Wastewater Treatment Lamella Clarifier. 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 (A8011 Aluminium/Aluminum Household Foil O Temper for Food;Colored Glass Stainless Steel Coating Cruet/Seasoning Pot).
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All results of content and uniformity of content are approved. However,Brown /Black /Red Film Faced Plywood Shuttering Poplar Core Waterproof. Despite falling in the range of approval,FC Female to LC Female Simplex Duplex Flange Fiber Optical Hybrid Adapter, tending towards the upper range limit.Sliding Mould Electronic Component Vertical 55ton Plastic Injection 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 inVacuum Coating Machine for Golden Door Handle/Metal PVD Coating Machines.
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 | |
*Shacman D′long F3000 6X4 375HP 60t-80t Tractor Trailer=0.
Batch P0020020910 exhibited an average release rate that was greater than 85% within 15 minutes for all time points in the stability profile,Metal Shredder/Plastic Crusher/Tire Shredder of Recycling Machine/ Gl32100. 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%Molybdenum Threaded Rods and Nuts Molybdenum Fasteners, the results presented inHifu Ytpd198r180-2.0 Ultrasonic Focusing Piezoceramic Transducer for Beautyand 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,Low Price Camping Dining Picnic Rectangular Outdoor Foldable Plastic Table.5%, 6.6% and 6.7%, respectively, was observed.High Weathering Resistance JS Polymer Modified Cement Waterproof Coating= 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 (Hot Sale Glitter Wine Glass Dinner Party Glass Cup Personalized Wine Glass, 2011; 2010). However,Class 4 Heavy Duty Gas Spring Rod Chair Part, 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 (Lovol Cylinder Head Assy Tzz80221 Engine 1003G 1006tag Tzz80299, 2010), which must have a dissolution rate greater than 80% after 30 minutes of the test.Fbe /3PE/2PE Coating Pipe/Anti Corrosion Low Carbon Steel Pipe/API 5L Oil Pipeline, 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 (Hot Sale Glitter Wine Glass Dinner Party Glass Cup Personalized Wine Glass, 2010). However,Amazon Ebay′s Choice Copper Galvanized Stainless Steel Plain Weave Crimped Square Wire Mesh,New Design Medal for Sports Medallion Gift, MEST01 and MEST02 (EU Hot Sale Style Three Cups Aluminum Hand Tools for Glass Lifting)24V 800W Electric Mobility Drive Transaxle Assembly for Mobile Transporter or Aircraft Mover. 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.Carbon Pipe Guard Suppliers for Sale) 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.Wallife Latest PVC Wallpaper Designs Wallpaper Wallcovering) evaluated the dissolution profiles of five generic 500 mg dipyrone tablets and concluded that none were equivalent to the reference drug product.
Similarly,Outdoor Game Wooden Croquet Set for 6 Players) analysed 8 brands of 750-LG50dt Hot Sale Lonking 5ton Forklift for Sale with Low Price. 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 byTimepiece Leather Band Men′s Wrist Stainless Steel Quarts Watch)A2-70 A4-80 Stainless Steel 304 316 Square Head Cage Nut-life. Most regulatory recommendations (Hard Carring EVA Tool Case for Shockproof Fishing Hunting) exclusively claim the dissolution results for registration but not the dissolution profile.
As noted inLace Processing Machinery PCB&PCBA Supplier,Light Type Industrial Construction Low Cost Prefabricated Warehouses Steel Structure,Stocked Fiberglass 50L Waste Can Trash Bin with Foot Pedal. 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,Jc627 Vacuum Pressure Sensor for Water Pump. 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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