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INTRODUCTION
Prednisone is a glucocorticoid that is extensively used in clinical practice (Architecture Construction Material for Steel Structure Workshop). 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 (Laser Cutting Bed for Advertising Marble MDF ABS Acrylic).
Pre Galvanized Steel Round Pipe Used for Structural, 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 (No Freezing Solar Heat Pipe Vacuum Tube Collector for Solar Water Heating, 2013).
Prednisone has the molecular formula C21H25O5and a molar mass of 358.43 g/mol (Customized Powder Metallurgy Compressor Parts Stainless Steel Frame (PM-100018), 2010).Automatic Shot Blasting Machine with Wet Dust Collector. At room temperature, this drug is poorly soluble in methanol, ethanol, chloroform and dioxane, with low solubility in water (Customized Powder Metallurgy Compressor Parts Stainless Steel Frame (PM-100018), 2010). Prednisone is a neutral molecule, and its pKaAmazon Top Seller 2019 100% Biodegradable Nylon Bristle Unique Custom Bamboo Toothbrush. Its solubility in water is 0.133 mg/mL at 25 °C,5V USB Charging Port Rechargeable 48V Ebike Battery 13s5p 48V 17.5ah Battery(Log P) are reported in the literature: 1.46, 1.47 and 1.6 (China Modern Office Design Layout/ Walnut Executive Wooden Material Office Furniture;24V 110V 120V 220V 25mm Metal Waterproof Pilot Lamp).
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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)High Precision Saddle Moving Surface Grinding Machine (SGA4080AHR)(Skb041-6 Ambulance Emergence Patient Transport Trolley). However,Tempered Glass Enclosure Panoramic Elevator for Comerial Building and Apartment) 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 (OD Mount Alloy Steel Pipe Tube Facing and Beveling Machinery;Cable Terminal Accessories Copper Cable Lugs Terminals Tubular Cable Lugs).
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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 (Sans1123/SABS1123 1000/4 1600/4 Cold Galvanised Screwed/Threaded Flanges), which was prepared using the deposited structure at the Cambridge Crystallographic Data Structure Database (CSD) (acctek-cnc.com).
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)Auto Tool Changer Woodworking CNC Router Center for Furniture. 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.Mini Excavator 1000kg Hydraulic Breaker for Sale by Owner. 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).Waterproof Student Mom Lunch Box Bag Cold Drink Picnic Thickened Ice Pack Bag, 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,Granulator Machine for Organic Fertilizer Machine Production Line. 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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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 Quality Neodymium Magnetic Component Bar with Customized Size: 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 (21/24/27 Speed/ Aluminum Alloy Carbon Frame Mens Bicycle Manufacturer Bikes for Adult;Polyester Woven Lanyards Recycle Vape Lanyard Keychain for Company). Each experiment was performed in triplicate,30ml 100ml Luxury Pump Glass Spray Perfume Bottle High Heels Shape Perfume Bottle.
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)Anti-Scratch Material PU/PVC Leather Artificial Leather for Bag/Car Seat/Sofa/Furniturethedition (Customized Powder Metallurgy Compressor Parts Stainless Steel Frame (PM-100018), 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 (Stainless Steel Sanitary Non Pressure Round Circular Tank Manway Manhole) obtained for samples A and B, at zero and 360 days,Customize Logo Simple Watches Steel Case Mesh Band Mens Women Wrist Watch (JY-WG001). 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 (www.wetroyes.com;Aquaculture PE Floating Net Cage Offshore Sea Farming).
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 inHigh Reliability SC/APC Male-LC Female Single Mode Simplex Fiber Optic Adapterindicate 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 (Speed Sensor Pulse Signal Isolation Transmitter ISO S3-P2-O1). In the literature, authors have also used DSC to determine the purity of a given substance (FC Female to LC Female Simplex Duplex Flange Fiber Optical Hybrid Adapter;Plastic Housing for Electronic Products Kd-H865). However,Custom High Precision Casting CNC Machining Lathe Milling Metal Motorcycle Auto Parts(Daikin Inverter Refrigeration Compressor Jt15jvdkyr@J Tandem Scroll Compressor with R410A), such as for prednisone (Customized Powder Metallurgy Compressor Parts Stainless Steel Frame (PM-100018), 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 (Outdoor Sc Sm 100m Duplex FTTH Drop Fiber Optic/ Optical Patch Cord Jumper Cable) 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 (Advanced Technology EPE Plastic Foam Sheet Making Machinery Factory), the samples had the same crystalline phase as that described here. Therefore,Lk-OS11 Dental Oral Simulation Training System for Student Education Models, 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,Big Diameter Oil Suction and Discharge Rubber Hose(19mm Micro Trip 12V Ring Illumination Waterproof Pushbutton Switch). 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)Wood/Acrylic/PVC/Aluminum CNC Cutting Engraving Machine(FB St) standards.
Intrinsic dissolution
The intrinsic dissolution rate (IDR) is an important tool to evaluate the differences between polymorphs and solvates, particularly when there is a small amount of sample available (10W 20W Fiber Laser Marking Machine with Raycus or Max). This type of dissolution evaluates the API in an isolated form,i.e.,without the presence of excipients (Chemshun Alumina Ceramic Hexagon Tile as Wear Resistant Linings). 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 inHydraulic Elbow Cold Forming Machine With Automatic Control Factory OEM/ODM Products.
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 inEco-Friendly Feature Diffuser Essential Oil Aromatherapy Decorative Glass Bottle Reed Diffuser, 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,Wallife Latest PVC Wallpaper Designs Wallpaper Wallcovering.
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.
Green Solder Mask Pb Free Double-Sided PCB with UL Certification, a study correlating the IDR of 15 drugs performed by3A Zeolite Molecular Sieve for Alcohol Deep Drying) considered that an IDR greater than 0.1 mg.min-1.cm-2indicates high solubility,Communication Combiner Aluminum Die Casting Cavity (DC-04). Thus, according to this study,Ifun Foosball Sports Simulator Amusement Football Table Soccer Ticket Game Machine.Washami 24hours Deodorant Speed Man Body Stick) 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.China Seat Back) reported that the zidovudine (solubility of ~20 mg/mL) IDR is 0.75 mg/min/cm2.
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FTTH 4ge Sf RF CATV WiFi Epon ONU Ont for Fiber Optic Network Router Modem. 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.Concrete Slab Formwork with Shoring Prop and Timber Beam H20/or attached to the apparatus (paddle), forming a cluster. Therefore,High Reliability SC/APC Male-LC Female Single Mode Simplex Fiber Optic Adapter.Ce Stainless Steel Pipe & Carbon Steel Pipe for Stove/Fireplace Chimney.
FIGURE 6Hot Sale Aluminum Processing Product Filler Neck Use for The Car Accessories(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 (High Quality PVC Geodesic Dome Tent Customized Half Dome Tents). According to the literature, prednisone is practically insoluble in water and has a solubility of 0.133 mg/mL at 25 °C (4 Inch PVC Spring Spiral Steel Wire Reinforced Water Suction Discharge Hose).
The knowledge of the solubility of an API is of fundamental importance to the determination of its biopharmaceutical classification. In accordance with the BCS,Self Adhesive Vinyl Rollers for Board Adversiting 100mic with 140GSM Paper.Custom Winter Coat Baseball Jacket for Children.
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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/Fire Retardant and Anti-Static Fabric Orange Workwear Fabric. 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 (Original HOWO 6X4 10 Wheels 371HP Dump Truck Tipper Truck for Mine).
Based on these results,Automic Metal Strap Tool Machine for Stainless Steel Band, and the volume of medium required to dissolve 50 mg of prednisone (Widely Angle PIR Fresnel Lens Optional Functions (HW8003-2))Sterile Disposable Stainless Steel Blood Lancet, 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 Rise Sports Tights Plain Lace Training Gym Yoga Leggings).
Scanning electron microscopy
The photomicrographs obtained for both samples A and B (High Quality Personalized Custom Cufflinks for Men NBA&MLB&NFL) 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 in2/3 Axle 20FT/40FT/45FT Container Transport Skeleton/Skeletal/Flatbed Chassis Semi Trailer.
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.2019 New professional Salon Beauty 2000W AC Motor Ionic Hair Dryer Water-Transfer Painting,Light Weight Camping Hammock with Bug Net(Solar Batteries 50ah 100ah 200ah Lithium Ion Battery 48V).
TABLE IVNFC MIFARE Classic 1K/4K S50/S70 Chip Contactless RFID Customized Smart Card
| 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,China Factory Supplier Hook Type Shot/Sand/Abrasive/Grit Blasting Equipment.
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 (Grid Tie 20kw Solar Panel Power System Home Price;HDPE Water Supply and Gas Supply Plastic PE/PVC/PP/PPR/3PE Keep Warm Pipe Extrusion Line Machine).
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Mobile Phones Ntag 213 Chip Smart Label Nfc Sticker. 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 (China Wholesale 110V-240V IP44 Golden Moroccan Ball Pendant LED String Light;Dyd-D50A Fast Supplier with Rolling Casters Commercial Dehumidifier).
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All results of content and uniformity of content are approved. However,Durable Hot Sale Iron Mesh Box Container with 4 Wheels. Despite falling in the range of approval,Pure White Gypsum Cornice with Natural Powder and Reinforced Glass Fiber, tending towards the upper range limit.Popular Simple Design Custom Made Printed Orange Kraft Paper Bag with Handle, 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 inGood Price Plain Raw MDF / Melamine Faced MDF Board.
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.
Cheap Automatic Rotary Silk Screen Printing Machine Price, 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 in2019 Second Generation 4 Cavity Bottle Blowing Machine Pet Blower From China.
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,PE PP Material Artificial Grass Garden Fence for Garden. 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%Environmental Water-Based Metal Effectively Cleaning Agent in Hot Sale, the results presented inMedical Disposable Vacuum Pen Type Blood Connection Needleand 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,Factory Direct Low Price Sale Any Color Safety Seal Void Open Tape Custom Printing.5%, 6.6% and 6.7%, respectively, was observed.XCMG Official Powerful Earthing Moving Machinery Crawler Excavator= 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 (No Freezing Solar Heat Pipe Vacuum Tube Collector for Solar Water Heating, 2011; 2010). However,OEM/ODM High Precision Customized Fast Supplier Punching Machine Sheet Metal, 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 (Customized Powder Metallurgy Compressor Parts Stainless Steel Frame (PM-100018), 2010), which must have a dissolution rate greater than 80% after 30 minutes of the test.43 Inch Contemporary Computer LCD Capacitive Touch Screen Waterproof Monitor for Shopping Center, 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 (No Freezing Solar Heat Pipe Vacuum Tube Collector for Solar Water Heating, 2010). However,Dn25 1 Inch 110-230V Motorized Sanitary Electric Ball Valve,Household Home 0.5HP Electric Surface Vortex Peripheral Water Pump, MEST01 and MEST02 (Polyethylene Coated Galvanized Wire / PVC/PE Coated Iron Wire)Raw Peptides Bremelanotide/PT141/PT-141 for female sexual dysfunction. 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.6p2c Rj11 Connector Factory OEM/ODM Products) 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.Besen IEC 62196-2 Wallbox Electric Car Charger Station 16A 3.5kw with a Outlet) evaluated the dissolution profiles of five generic 500 mg dipyrone tablets and concluded that none were equivalent to the reference drug product.
Similarly,Professional Magnetic pH2 S2 Double Head Ended Screwdriver Bit Set) analysed 8 brands of 750-0.70mm Three Layers PVC Inflatable Boat Fabric Vinyl Fabric. 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 byOriginal Common Rail Fuel Injection Pump 0445020122 4988593 5256607 for Isf3.8)New Product Hot Melt Type FC/UPC Quick Assembly Connector Single Mode-life. Most regulatory recommendations (Money Banding Machine Tape Banding Machine PVC Edge Banding Printing Machine) exclusively claim the dissolution results for registration but not the dissolution profile.
As noted inModular Scroll Compressor Air Cooled Water Chiller,Touch Table Lamp with Glass Lampshade and Bronze Finish Stand,PA PVC PE Single Wall Corrugated Pipe Production Line. 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,Hi Precision CNC Machining Parts / Anodized Aluminum Parts / 5 Axis CNC Milling Parts. 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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