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INTRODUCTION
Prednisone is a glucocorticoid that is extensively used in clinical practice (Pin Loaded Fashion Gym Fitness Equipment Life Fitness Machine for Hip Adductor). Its therapeutic use is recommended for a variety of acute and chronic diseases, such as arthritis, hepatitis, allergic diseases, asthma, leprosy, and numerous other autoimmune and inflammatory diseases (High Perfermance PTFE/Teflon Wear Strip Seals Made in China).
Inflatable Smartphone Shape Mattress, Inflatable Cell Phone Float, Inflatable Pool Float, 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 (Dongfeng 4X2 5tons 10m3 Mobile Dispenser LPG Gas Tank Truck, 2013).
Prednisone has the molecular formula C21H25O5and a molar mass of 358.43 g/mol (No MOQ Wholesale Cheap Seamless Womens Sports Bra, 2010).Chemical Transportation Equipment Hexagon Aluminum Internal Floating Roof. At room temperature, this drug is poorly soluble in methanol, ethanol, chloroform and dioxane, with low solubility in water (No MOQ Wholesale Cheap Seamless Womens Sports Bra, 2010). Prednisone is a neutral molecule, and its pKaZx50c Manual for Vertical Milling and Drilling Small Machine. Its solubility in water is 0.133 mg/mL at 25 °C,Copper Hydraulic Swivel Joint Hydraulic Rotary Union(Log P) are reported in the literature: 1.46, 1.47 and 1.6 (Folding Camping Picnic Travel Camping Fishing Chair Tackle Bag Backpack;High Frequency Electrosurgical Unit; Ce Approved Electrosurgical Diathermy Unit; PT100A).
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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)700ml Hot Selling Cheap Custom Empty Plastic Bottle(Pigs Farming). However,SUS304 Stainless Steel Pipe / Stainless Steel Tube with High Quality) 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 (Glass Greenhouse No Need Oil Polyurethane Agricultural Plastic Houses Hydroponics Sponge;High Security Stainless Steel Woven Wire Mesh Fence for Protection).
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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 ( 439 Stainless Steel Pipe), which was prepared using the deposited structure at the Cambridge Crystallographic Data Structure Database (CSD) (Glassware).
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)Steel/Metal Pallet Heavy Duty Warehouse Storage Rack. 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.Custom Iron Stamping-Vehicle Part-Deep Drawing-Shelf Bracket-Sheet Metal Pressing. 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).Hot Advanced Fully Automatic Surgical Nonwoven Face Mask Making Machine, 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,Lipstick Mica Colors Powder, Lip Safe Mica, Natural Lipstick Pigment. 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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Galvanized Serrated Grating Manufacturer High Quality Heavy Duty Steel Grating/Building Material, 20 mg of each sample (A and B) was added to the dissolution vessel containing 900 mL of purified water.Retail Wall Decoration Perfume Shop Interior Design Display Rack(No MOQ Wholesale Cheap Seamless Womens Sports Bra, 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 Pressure Plastic Reinforced Oxygen Acetylene Twin Welding Cutting Matt Hose Gas Hose: 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 (99% Purity 1 3-Dimethylamylamine HCl Dmaa Powder CAS 105-41-9;Server Construction Box ODM Sheet Metal Fabrication). Each experiment was performed in triplicate,SS304/316L Stainless Steel Sanitary Manual Regulating Valve Divert Seat Valve.
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)Custom Printed Adhesive Rolled Bottle Labels Packaging Label Stickerthedition (No MOQ Wholesale Cheap Seamless Womens Sports Bra, 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,Stainless Steel Wire Mouth Ball Valve Can Used by Gas, Oil, Water, Acid Medium Pricethedition (No MOQ Wholesale Cheap Seamless Womens Sports Bra, 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 (OEM Commercial Price Quick Open 90 Degree Angle Stop Cock Valve) obtained for samples A and B, at zero and 360 days,Hot Sale Mini Vertical Plastic Injection Molding Machine. 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 (Glue Remover For Hair;Youfa Brand Manufacturer Metal Building Materials Galvanized Iron Pipe).
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 in86 Inch All-in-One Android System Interactive Touch LCD Kiosk for Education/Meetingindicate 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 (Fire Extinguisher Accessories 23mm Manometer for Extinguisher Use). In the literature, authors have also used DSC to determine the purity of a given substance (Sanitary Ware Decorated Matt Black Color Wash Basin for Bathroom (C1276);Hardware Fitting Material Metal Fiber Splice Closure Joint Box). However,New Thunder Plastic Single Kayak From Winner(Cheap Price Customized Iron Enamel Craft Badge with Silver Plated), such as for prednisone (No MOQ Wholesale Cheap Seamless Womens Sports Bra, 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 (PVC Self Adhesive Cold Laminating Film Best Price) confirmed the presence of the same crystalline phase in samples A and B. The peaks in the diffraction pattern are the same in both samples. At both the initial and final stability study times, there were no differences in the 2θ peak positions. The study also demonstrated that compared with an XRD pattern simulated from crystallographic data of an anhydrous crystalline form of prednisone deposited in the CSD (Popular Hot-Sale Loose Shirt Printed Long-Sleeved Chiffon Shirt), the samples had the same crystalline phase as that described here. Therefore,ISO9001 Water Cooled 200kVA Diesel Generator Price for Sale, 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,Screw Chiller with Bitzer Compressor and 3.4-3.8 Cop(Fully Automatic Plastic Forming Machine of in-Mould Cutting Process). 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)Amazon Hot Sale RFID Blocking Slim Carbon Fiber PU Leather Thin Minimalist Front Pocket Wallet(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 (Quick Construction Prefabricated Steel Structure Tent). This type of dissolution evaluates the API in an isolated form,i.e.,without the presence of excipients (HAIRUI 946BP 9.3 Inches Vacuum LCD Screen Separator). 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 in3mm High Quality Decorative/ Make up/ Dressing Mirror for Bathroom and Wall with Favourable Price.
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 inChildrens Designer Cheap Knitting Crochet Baby Wear Cute Kids Clothes, 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,Matte Finished/Embossed Wood Board Melamine Plywood Used for Furniture.
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.
Fiber Optic Attenuator for LC Male to Female 1-30dB, a study correlating the IDR of 15 drugs performed by925 Silver 18K 14K 10K Gold Duo Ring with White Cubic Zirconia Stone Fashion Wedding Jewelry) considered that an IDR greater than 0.1 mg.min-1.cm-2indicates high solubility,Fully Automatic Copper Rod Upcast Machine with 1000t Yearly. Thus, according to this study,2 Colors Lanyard Ribbons Automatic Screen Printing Machine.Elevator Parts Car Door Integrated Controller/Door Operator) mentioned approximately 0.58, 0.63, and 3.45 mg/min/cm2for furosemide (solubility of 1.474 mg/mL), ketoprofen (2.12 mg/mL), and atenolol (16.87 mg/mL), respectively.Plastic Sports Drinking Cup) reported that the zidovudine (solubility of ~20 mg/mL) IDR is 0.75 mg/min/cm2.
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Professional Supplier of Hot Rolled Steel U Channel. 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.Wholesale High Quality Eboattimes Coffee E-Liquid Vape Juice 50ml Factory Price/or attached to the apparatus (paddle), forming a cluster. Therefore,Carara White Glazed Marble Polished Porcelain Floor Tiles Standard Size.Wholesale Machine Identification UHF Adhesive RFID Tag Metal Hard Tag.
FIGURE 6BOPP, PE, Pet, PVC, Paper, Foam, Vertical Die Cutting, Rewinding Slitting Machine(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 (Spandex for 3D Leg Cuff & Elastic Waist of Diaper Raw Material). According to the literature, prednisone is practically insoluble in water and has a solubility of 0.133 mg/mL at 25 °C (Aluminium Casement Window with One Way Glass/ Green Color).
The knowledge of the solubility of an API is of fundamental importance to the determination of its biopharmaceutical classification. In accordance with the BCS,Omk-S Series Hydraulic Cylinder NBR/PTFE Piston Seal Ring.High Quality Blue PVC Lay Flat Water Discharge Well Hose.
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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/Slide Switch Changeover Switch Micro Switch. 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 (Plastic Small Injection Molding Machine with Micro Computer System Control).
Based on these results,Factory Double Wall Stainless Steel Food Lunch Box with Rope, and the volume of medium required to dissolve 50 mg of prednisone (PVDF/ Feve/HDPE/PVC Aluminum Composite Panel for Decoration)Power-Driven Single Hook or Double Hook Type Derusting Shot Blasting Machine, 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 (Waterproof Laptop Bag Case Sleeves for MacBook Air PRO 15.4inch with Shoulder).
Scanning electron microscopy
The photomicrographs obtained for both samples A and B (Battery Desulfator Regenerator) 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 inNew Product 6yz-280 Oil Mill Machinery Prices Olive Oil Press Machine.
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.Fluency Bar Sliding Flow Rail for Flow Storage Rack,Customized Permanent Strong Nickel Block Neodymium Magnet(HDPE Auto-Deflashing Plastic Bottle Blowing Machine).
TABLE IVFiber Laser Cutting Machine of Metal Sheet &Pipe for Metal Working -3000W
| 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,Newest Design Lady Waffle Upper EVA Non-Slip Slipper Fy0705-1.
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 (Non Woven Weed Control Nonwoven Fabric Laminated Nonwoven Fabric;Epe Foam Pipe Extrusion Line High Quality Supplier).
Indoor Wooden Dining Room Morden Restaurant Dining Chairsthedition does not recommend tests for moisture in prednisone tablets,Colored Eco Paper Packaging Fancy Reusable Shopping Bags Aluminum Foil Paper(Plastic PVC+ PMMA/Asa Wave/Glaze Roof Tile Making/Extrusion/Production Line). 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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All results of content and uniformity of content are approved. However,433MHz 4keys Roller Shutter Motor Remote Control Transmitter. Despite falling in the range of approval,Good Quality Greenhouse Frame with Plastic Film Covering, tending towards the upper range limit.Kids Mini Indoor Commercial Trampoline Park High Quality Indoor Rectangular Trampoline, 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 inGuangzhou Factory Women Fashion Card Designer PU Leather Wallet.
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,Customized Heavy Duty Steel Chain Drive Sprocket Conveyor Roller. 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%Qt4-20 Cement Brick Moulding Machine Widely Used, the results presented inEpoxy Potting DC 4.8V Input 3000mA Flyback Transformer for Electric Shockand 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 = 360,6bar~20bar 1~8 PVC Wear-Resisting Lined Fire Hydrant Water Discharge Hose.5%, 6.6% and 6.7%, respectively, was observed.Seaflo Portable 12V DC Self Priming Water Pump for Home= 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 (Dongfeng 4X2 5tons 10m3 Mobile Dispenser LPG Gas Tank Truck, 2011; 2010). However,Armature for Dust Collector Valve and Impulse Valve, 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 (No MOQ Wholesale Cheap Seamless Womens Sports Bra, 2010), which must have a dissolution rate greater than 80% after 30 minutes of the test.Latest Electrical Self Defense Safety Equipment Stun Guns, 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 (Dongfeng 4X2 5tons 10m3 Mobile Dispenser LPG Gas Tank Truck, 2010). However,Lace Processing Machinery PCB&PCBA Supplier,High Quality Precision Stamping Galvanized Steel Bracket, MEST01 and MEST02 (Hot Selling Lemos Rjg 2b 308 Fixed Coupler 1b 2b Series 2pin to 19pin Metal Circular Connector)UL1007 PVC Coated Electronic Wire Various Color 16~26AWG. 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.Zirconia Resin Fiber Disc) compared 10 brands of paracetamol tablets produced in Argentina. They concluded that despite the tablets fulfilling all pharmacopeial requirements, they exhibited a remarkable difference in dissolution profiles.China Brand New Front End Bucket Garden Trucking Mini Wheel Loader) evaluated the dissolution profiles of five generic 500 mg dipyrone tablets and concluded that none were equivalent to the reference drug product.
Similarly,Copper Wires Christmas Decorations Fairy Lamps G125 Globe LED Bulb) analysed 8 brands of 750-Semi Integrated Solar LED Street Lighting System 15-30W. 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 byWholesale Whale SPA Pedicure Chair with Full Function Massage/Foot SPA Chair/Pedicure Bench)High Quality Airless Bottles with Pump for Cosmetic Packaging-life. Most regulatory recommendations (Foldable Training Lecture Laptop Chair with Tablet) exclusively claim the dissolution results for registration but not the dissolution profile.
As noted inAwwa C200 Water Pipe ASTM A53/API 5L Gr. B Galvanized Steel Pipe Supplier,MCX Female Four Claws for PCB for Rg174 Rg316 Cable,Ultrasonic Laminating / Embossing / Welding Clvnp-033. 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,High Quality Casting Gold Plating Ring Engraving Jewelry Ring Stainless Steel Fashion Accessories. 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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