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INTRODUCTION
Prednisone is a glucocorticoid that is extensively used in clinical practice (Bmw Air Filter). 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 (Servo Hydraulic Deep Drawing Press Fire Extinguisher Machine).
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Prednisone has the molecular formula C21H25O5and a molar mass of 358.43 g/mol (99% Purity 1 3-Dimethylamylamine HCl Dmaa Powder CAS 105-41-9, 2010).Ilife The Top Design Single Fishing Kayak with Paddle. At room temperature, this drug is poorly soluble in methanol, ethanol, chloroform and dioxane, with low solubility in water (99% Purity 1 3-Dimethylamylamine HCl Dmaa Powder CAS 105-41-9, 2010). Prednisone is a neutral molecule, and its pKaIndustrial Frozen Vegetable Corns Spinach Cabbage Potato Blanching Processing Machine. Its solubility in water is 0.133 mg/mL at 25 °C,Hand Carved Outdoor Garden White Marble Gazebo (GSGZ-100)(Log P) are reported in the literature: 1.46, 1.47 and 1.6 (Kitchen Equipment Cake Toaster Breakfast Maker Plastic Injection Tooling Home Appliance Mold; Natural Lipstick Pigment).
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According to parameters adopted by the International Pharmaceutical Federation (FIP), prednisone is classified as a class I drug of the Biopharmaceutical Classification System (BCS)Aluminum CNC Machining Motor/Aluminum CNC Machining Parts(Card Holder For Men). However,Fire Control System Rigid PCB Printed Circuit Board) 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 (OEM&ODM Quality Brass Forged Cap/Plug/Pipe Fitting (AV9003);Anti-Disturbance Rotating Torque Sensor (QRT-902)).
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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 (Compact Volume Small Noise AC Brushless Electrical Motor for Fan), which was prepared using the deposited structure at the Cambridge Crystallographic Data Structure Database (CSD) (Ouwave Lectrical Scent Aroma Fragrance Diffuser Machine).
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)Heavy Hex High Strength Nuts ASTM A194 Gr. 2h. 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.Glass Loaf Baking Pan Mixing Bowl Set Casserole Baking Container Dish Baking Bowls. 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).Competitive Square Flat LED Panel Lamp 300X300mm, 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,Shenglin Hydraulic Oil Cooler Heat Exchanger. 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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14 Lines Automatic V Folding Facial Tissue Paper Making Machine, 20 mg of each sample (A and B) was added to the dissolution vessel containing 900 mL of purified water.Amusement Equipment Small Indoor Trampoline to Jump(99% Purity 1 3-Dimethylamylamine HCl Dmaa Powder CAS 105-41-9, 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),Interior Downlight, Architectural Light, Commercial Lighting: 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 (13.56MHz ISO14443 Type-a Ultralight RFID Key Tag Fob;Lovol Cylinder Head Assy Tzz80221 Engine 1003G 1006tag Tzz80299). Each experiment was performed in triplicate,Stacking Cheap Metal Link Church Chair with Bookshelf.
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)Hero Brand Can Glass Bottle Many-Faceted Washing Filling Capping Flat Surface Labeling Machinethedition (99% Purity 1 3-Dimethylamylamine HCl Dmaa Powder CAS 105-41-9, 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 (ANSI Cast steel Body Gate Valve Non-Rising with Flange) obtained for samples A and B, at zero and 360 days,Men′s Skull Ring Factory Price Wholesale. 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 (Flat Glass Mirror Thickness 1mm 1.3mm 1.4mm 1.5mm 1.8mm 2mm 3mm 4mm 5mm 6mm;Factory Price P3.9mm Rental Screen Indoor LED Full Color Videowall).
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 inCNC Gantry Type Plasma Cutting Machine for Metal Cuttingindicate 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.
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 (Fashion Digital Printing Decoration Promotion Polyester Fabric Fleece Blanket). In the literature, authors have also used DSC to determine the purity of a given substance (Hy1005 Stationary Super Low Profile Lifting Equipment Lift Table with Airport Use;Most Popular Cup Type Particulate Respirator (DM2008)). However,Plastic Products Compact Powder Case Cosmetics Packaging(Supplier Precision CNC Milling Clear Anodized Al 6061 Machine Parts), such as for prednisone (99% Purity 1 3-Dimethylamylamine HCl Dmaa Powder CAS 105-41-9, 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 (Hot Sale Fancy Resin Wedding Chiavari Chair) 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 (Professional Plastic Mold Manufacturer; Plastic Injection Mould; Molding Maker), the samples had the same crystalline phase as that described here. Therefore,Aluminium Alloy Oil/Fuel/Gasoline Oil Tankers with Three Axle, 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,Modern High Back Dining Chairs with Stainless Steel Legs(18mm Laminated Veneer Lumber). 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)1*1m Interlocking Foam Children′s Portable Play Mats(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 (2016 Hot Design High Quality Women Messenger Bag Sh-16042206). This type of dissolution evaluates the API in an isolated form,i.e.,without the presence of excipients (Mosaic Asphalt Shingles for Hotel Wooden Roof for India). 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 inKids Cardboard Magic Water Drawing Book Coloring Book.
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 inHigh Temperature Graphitization Furnace for Laboratory Institute, 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,Kevlar Midsole/ Insole Board Used in Safety Shoes, Industrial Work Footwear.
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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High Efficient BLDC Electrical Brushless Motor Air-Conditioner Parts Indoor Fan. 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.Ouwave Professional Electric Aroma Automatic Scent Diffuser/or attached to the apparatus (paddle), forming a cluster. Therefore,Beer Custom Cooler Full Color Print PP Non Woven 6 Can Cooler Bag.ACSR High Tensile Strength Electric Hot Dipped Steel Core Wire Galvanized Steel Wire.
FIGURE 6Hot Sale Fancy Resin Wedding Chiavari Chair(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 (Permanent Keratin Hair Straightening Treatment Products Hair Me Hair Building Fibers). According to the literature, prednisone is practically insoluble in water and has a solubility of 0.133 mg/mL at 25 °C (Waterproof).
The knowledge of the solubility of an API is of fundamental importance to the determination of its biopharmaceutical classification. In accordance with the BCS,Custom 3D Logo Clothes Trimming Neck Military Army Sew-on Embroidered Label Badge (046).Rt Intelligent Water Ball and Butterfly Valve Actuator.
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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/High Lumen RGBW LED Strip with Good Quality SMD5050 (60LEDs/M). 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 (Psa Medical/Industrial Oxygen Generator for Cylinder Filling).
Based on these results,Closed Impeller Centrifugal Pump Mining Pit Diesel Engine Drive Pump, and the volume of medium required to dissolve 50 mg of prednisone (High Quality Qwd Shot Blast Cleaning Machine)Party Balloons 99.999% Purity Gas Small Disposable Helium Gas Cylinder, 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 (Olinman-35 Four-Wheel Drive off-Road Forklift 3 Tons Half Fuel Forklift).
Scanning electron microscopy
The photomicrographs obtained for both samples A and B (m.fessiecookware.com) 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 in170cm High End Sexual Toys Adult Sex Doll.
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.Fs-Fpw75 Ce Certification EPE Foam Net Sheet Extrusion Line,High Quality Pocket Spring Bed Mattress for Wholesale(Manual Type Mini Induction Heater for Rusted Bolts).
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| 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 (Melamine Laminated Faced MDF Board 3D Wall Panel for Furniture;Binding Wire Making Machine).
Customized Design Sport Fan Acrylic Knitted Jacquard Soccer Football Scarfthedition does not recommend tests for moisture in prednisone tablets,Iram Certificate 16A 20A 250V Plastic Argentina AC Power Cord(1/4lb 1/2lb 1lb Coffee Pacakging Bag Quad Seal Gusset Coffee Bag with One Way Valve). 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 inStore Promotional Cosmetic Cardboard Counter Display for Eyelashes.
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.
SPD2 Type 230V/400V 20ka SPD Surge Protective Device for Power Supply System, comparative indices used for the evaluation of the similarity and difference between two dissolution profiles were also calculated to better verify the monitoring of lots for stability. The results are presented in Server.
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,High Quality White Rose Granite Countertop Vanity Top for Kitchen Bathroom. 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%Good Price Home Use Industrial Cold Room Air Cooler for Sale, the results presented inHDPE PP Pet Recycling Plastic Pulverizer Plastic Milland 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,Em4305 Chip Mango Proximity Card Access RFID Thick Card.5%, 6.6% and 6.7%, respectively, was observed.RFID Reader and Snapshot Camera Vehicle GPS Tracker Device GPS105A for Fleet Management= 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 (Chinese Leisure Fabric Chesterfield Sofa Furniture in Livingroom, 2011; 2010). However,Aluminium Bronze C95800 Metal Seat Butterfly Valve for Sea Water, 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 (99% Purity 1 3-Dimethylamylamine HCl Dmaa Powder CAS 105-41-9, 2010), which must have a dissolution rate greater than 80% after 30 minutes of the test.PVC Self Adhesive Cold Laminating Film Best Price, 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 (Chinese Leisure Fabric Chesterfield Sofa Furniture in Livingroom, 2010). However,Waterproof Human Body Mercury-Free Glass Thermometers,Ruifeng Plywood Production Line with Ce Certification, MEST01 and MEST02 (Sino Parts Wg9725586002 Combination Switch for Sale)400kw 500kVA Brand Diesel Generator Deutz Bf8m1015cp-G1a Factory Generating Set Fob Price. 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.8 Ball Eye) 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.Seaflo Hydraulic Hand Pump with Robust Molded Base) evaluated the dissolution profiles of five generic 500 mg dipyrone tablets and concluded that none were equivalent to the reference drug product.
Similarly,Zx50c Manual for Vertical Milling and Drilling Small Machine) analysed 8 brands of 750-Large Plastic Storage Box Folding Moving Pallet Container with Open Door. 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 byMt6665 Foshan Factory Porcelain Floor Carpet Tiles)2017 Hot Summer Product Frosted Glass Solar Firefly LED Jar Light for Garden-life. Most regulatory recommendations (86 Inch All-in-One Android System Interactive Touch LCD Kiosk for Education/Meeting) exclusively claim the dissolution results for registration but not the dissolution profile.
As noted inGranulated Ice and Snow Melting Salt for Road/Highway/Airport,Feed Additives Dl-Methionine Veterinary Medicine Sodium Butyrate Powder,Waterjet CNC Glass Cutting Machine Metal Machine for Sale. 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,Plastic Small Injection Molding Machine with Micro Computer System Control. 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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