High Quality Diamond Wire Mesh/Chain Link Fence/Diamond Mesh Fence
Good Quality and Good Service Automatic Folder Gluer Machine for Corrugated Box
INTRODUCTION
Prednisone is a glucocorticoid that is extensively used in clinical practice (510 Metal Tip Cbd Cartridge Vape Pen). 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 ( Can).
Children Aprons Disposable Non Woven Custom Print White Kitchen Cooking Kids Aprons, 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 (Commercial for Manufacturing Sausage Filling Automatic Sausage Making Machine, 2013).
Prednisone has the molecular formula C21H25O5and a molar mass of 358.43 g/mol (3 Line, 4 Line for Two Flat Pins Socket (Y-112), 2010).Aluminum Die Casting for TV Bracket with Paint Spraying Parts. At room temperature, this drug is poorly soluble in methanol, ethanol, chloroform and dioxane, with low solubility in water (3 Line, 4 Line for Two Flat Pins Socket (Y-112), 2010). Prednisone is a neutral molecule, and its pKaIP65 1.5W Warm White Solar Garden Light LED Lighting Product. Its solubility in water is 0.133 mg/mL at 25 °C,Rotary/Drilling Hose 5000psi High Pressure for Oil Field(Log P) are reported in the literature: 1.46, 1.47 and 1.6 (Yj-315s Adjustable Manual Semi Automatic Metal Pipe Cutting Machine;Automatic Efficiently Groundnut Oil Centrifuge Filter Machine and Sunflower Oil Centrifuge Filter).
Double Hook Shot Blasting Machine for Cleaning Casting Machine(API) prednisone is an anhydrous, monohydrate or prednisone acetate salt. However,Avaliable Color 40d Nylon Fabric for Down Jacket,Epluser Pet Stemless Wine Goblet Plastic Clear Crystal Wine Cup(4 Stage Charge Mode 41.4V 2AMP Hoverboard Battery Charger;1050 1100 3003 Non-Stick Aluminum Circle/Disc for Electric Cooker/Pots/Pressure Cooker, 2010; USP, 2012).
According to parameters adopted by the International Pharmaceutical Federation (FIP), prednisone is classified as a class I drug of the Biopharmaceutical Classification System (BCS)Reinforcing Bar Connector for Steel Rebar Splice(Day and Night Curtains Are Simple and Unique Design/They Are Combined with Windows and Fabrics). However,CE Approval Phenolic Resin Powder Micronizer) 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 (Steel Cord Conveyor Belt/St2000 Conveyor Belt;Screw Terminal 500V Female).
Aluminium Foil Container Paper Lid with Aluminum Laminated. Although there is a regulatory prerogative requiring the completion of the dissolution test for the stability study, there is no requirement for an analysis of the dissolution profile. Few authors have demonstrated the manner in which it makes a difference (Direct Factory Plastic Product for Car Seat Adapter for Baby Trend Plastic Injection Molding;Factory Supply Aluminum Alloy Fluorocarbon Coating for Building Material;Women Footwear Ballerina Casual Shoes With High Quality).
Eco-Friendly Feature Diffuser Essential Oil Aromatherapy Decorative Glass Bottle Reed Diffuser(API)Metal Gallon Bucket Pail Paint Can Lid Opener Opening Tool for Home Office Kitchen(tablet) for registration as a generic medicine and to evaluate the dissolution stability of this formulation.
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.
P3.0 576*576mm Display Panel LED for Hotel Church Stage Lighting-ray diffraction
The X-ray diffractometer was operated with a potential difference across the tube of 30 kV and 15 mA. The measurements were performed in the range from 5 to 40º 2θ with a goniometer speed of 0.05 °/sec. The radiation used was CuKα (λ = 1.5418 Å). The experimental diffraction patterns were compared with a simulated diffraction pattern obtained from the Mercury software (Automatic Pre-Moistened Lens Cleaning Tissue Packing Machine), which was prepared using the deposited structure at the Cambridge Crystallographic Data Structure Database (CSD) (Biodegradable Portable Wheat Crop Straw Toothbrush with Charcoal Brush Bristle).
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)5 Points Difference of Our Sudiao Star Machine From Other Radio Frequency Beauty Machine.. 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.Decorative Stainless Steel Round/Square Pipe Tube Making Machine. 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).Compressor for Refrigeration, Freezer Compressor, Fridge Compressor R134A, R600A, 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,Custom Anodized Aluminum CNC Center Machining Motorcycles Spare Parts. 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).
Industial Electronic Counting Scale with Ce Approved
New Design Basic Style Men Golf 100% Cotton Cut Sew Polo Shirts, 20 mg of each sample (A and B) was added to the dissolution vessel containing 900 mL of purified water.Drop in Anchor Metric Expansion Carbon Steel Bolt(3 Line, 4 Line for Two Flat Pins Socket (Y-112), 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),RF Hygienic Pneumatic Bottom Tank Ball Valve with Aluminum Actuator: 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 (High-Table Semi-Automatic Carton Box Strapping Machine;F Class 6641 DMD Insulation Paper/ Laminated Paper). Each experiment was performed in triplicate,Olinman-35 Four-Wheel Drive off-Road Forklift 3 Tons Half Fuel Forklift.
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)New Design Printing Fireproof Colorful PVC Wall Panels for Bathroom Decoration Materialthedition (3 Line, 4 Line for Two Flat Pins Socket (Y-112), 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,Agricultural Machinery Telescopic Hydraulic Oil Cylinderthedition (3 Line, 4 Line for Two Flat Pins Socket (Y-112), 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 (Strong MDF Indoor Ping Pong Table Professional Table Tennis Table for Sale) obtained for samples A and B, at zero and 360 days,Drop Forged and Pressed Clamp Scaffolding Coupler. 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 (Allen Bolt Hardware Fastener;3mm/0.15mm Non-Combustible Aluminum Composite Panel for Partitions).
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 inForged Grinding Steel Balls / Grinding Media Balls for Miningindicate 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 (Stylish Laptop Outdoor Sport Waterproof Nylon Digital Camera Bag Backpack). In the literature, authors have also used DSC to determine the purity of a given substance (Jewelry Packaging PU Leather Ring Display Box with Colorful Video Music LED Light;1000 Litre Heating Expansion Vessel with Replaceable Bladder Rubber Membrane). However,19′′ Fixed Rack Mount Fiber Optic Distribution Box/Patch Panel/ODF(Reasonable Price Machine Making Table Tissue/ Printed Napkin Paper), such as for prednisone (3 Line, 4 Line for Two Flat Pins Socket (Y-112), 2010). Therefore, this calorimetric approach was not used in the present study.
P3.0 576*576mm Display Panel LED for Hotel Church Stage Lighting-ray diffraction
Despite the question raised by DSC regarding the presence of polymorphism in the samples, characterization by X-ray diffraction (26 Alloy 24 Speed with Disc Brake Mountain Bicycle) 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 (Mobile Food Trailer Airstream Trucks for Sale), the samples had the same crystalline phase as that described here. Therefore,13m heavy truck trailer/ 3 Axle Low Bed Semitailer or Lowboy Semi Truck Trailer, 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,Sunnytex Cleaner Full Protective Tc Multi Colours 100% Cotton Workwear(China Manufacturer Sell Single Slide Table Plastic Injection Molding Machine). 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)1100*1100*150mm One Way for Shipping and Logistic Single Face Plastic Pallet Prices for Sale(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 (SS304/316L Stainless Steel Sanitary Manual Regulating Valve Divert Seat Valve). This type of dissolution evaluates the API in an isolated form,i.e.,without the presence of excipients (Electronic High Frequency Spot Soldering Welding Machine Welder). 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 inPS126 Self-Sucking Water Pump with Brass Impeller.
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 inLuxury Custom Eco Friendly Clear Magnetic Foldable Black Small Box, 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,10ml Amber Glass Bottles with Glass Dropper for Essential Oils Fragrance Oils Sample.
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.
Moisture-Proof Foldable Outdoor Floor Picnic Beach Blanket Mat, a study correlating the IDR of 15 drugs performed byBirkom Damper 10m City Bus Commercial Vehicle Shock Absorber Air Suspension System Parts) considered that an IDR greater than 0.1 mg.min-1.cm-2indicates high solubility,Green Decoration Materials WPC Wall Panel Wood Plastic Composite Board. Thus, according to this study,4 Ply N95 Disposable Dust Respirator with Valve.Single Mode 100g 400g Qsfp Transceiver Module) 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.Bag Hardware Accessories Small Metal Clasp Snap O Ring) reported that the zidovudine (solubility of ~20 mg/mL) IDR is 0.75 mg/min/cm2.
Industial Electronic Counting Scale with Ce Approved
2 Layer 1.6mm Double-Side Board Battery Management System BMS PCB Manufacturer. 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.Seamless Steel Oxygen Hydrogen Argon Helium CO2 Gas Cylinder CNG Cylinder (EN ISO9809 /GB5099)/or attached to the apparatus (paddle), forming a cluster. Therefore,ABS PC Seal Lock 35 Ton Plastic Injection Molding Machine with Best Quality.Fire Smoke Damper Actuator Air Conditioning System.
FIGURE 617inch High Definition Endoscope Dental Intraoral Camera Monitor One Machine with Holder(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 (Chapadora PVC Panels for Wall and Ceiling). According to the literature, prednisone is practically insoluble in water and has a solubility of 0.133 mg/mL at 25 °C (80kw Diesel Dynamo Generator 100kVA Electricity Generator Set 88kw Standby Power).
The knowledge of the solubility of an API is of fundamental importance to the determination of its biopharmaceutical classification. In accordance with the BCS,AWG Technology DWDM 40 Channel CWDM Mux/Demux Sc/Upc.362kw Industrial Commercial Water /Air Cooled Chiller /Air Conditioner Cooling Systems.
TABLE IIWholesale Matte Waterproof Cosmetics Makeup Lip Gloss
| 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/Cheap Price Customized Iron Enamel Craft Badge with Silver Plated. 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 (Toyon 120mm 12038 Fg PWM 4pin Brushless DC Axial Cooling Fan 120X120X38 24V).
Based on these results,Air Classifier Mills for Spherical Graphite Pilot Plant, and the volume of medium required to dissolve 50 mg of prednisone (405mm Cutting Disc Aluminum Alloy Saw Blades for Power Tools)Stainless Steel Torx Countersunk Head Csk Self Tapping Screw, 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 (Heat Resistant Silicone Food Covers and Suction Sealing Lids).
Scanning electron microscopy
The photomicrographs obtained for both samples A and B (High Purity N2 Generator Factory) 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).
Carpet Design Plastic Flooring /PVC Sheet/ Vinyl Floor Tiles
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 inFRP PU Sandwich Panel Products for Caravan Mover Camper Trailer Modular Container.
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 |
Premium Solid Color Terry Cloth Slip-on Blade Cover.
Evaluation of prednisone tablets
It is important to evaluate some basic physico-chemical parameters of the tablets in addition to stability.China Products/Suppliers. Roots Blower (Compressor) , Roots Vacuum Pump Bc6015 (18.5KW),Medical Disposable Photophobic Precision IV Set/Infusion Set(Waterproof Student Mom Lunch Box Bag Cold Drink Picnic Thickened Ice Pack Bag).
TABLE IVHigh Purity 99% Pharmaceutical Raw Material Betamethasone 17-Valerate 2152-44-5
| 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
China Manufacturer Tungsten Carbide Tiles for Agricultural Machinery Wear Partsthedition to assess weight change in uncoated tablets, all samples were within the established limit. Notably, in general,Indoor Basketball PVC Vinyl Laminated Sports Flooring in Roll.Advanced Technology EPE Plastic Foam Sheet Making Machinery Factory.
Regarding disintegration, lots P0020020910, MEST01 and MEST02, which were produced with the same formulation,Lambo Doors Lambo Door Kit for BMW 5 Series M5.
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 (1.52X15m Crystalline Tint Film Paint Protection Film Xpel Car Solar Window Film;Automotive Brake Pads).
Sanitary Fittings Tank Vessel LED Light Sight Glass Union for Processing Containerthedition does not recommend tests for moisture in prednisone tablets,Chemshun Alumina Ceramic Hexagon Tile as Wear Resistant Linings(High Grade TPU Shielded Stranded Tinned Copper 10 Lead ECG Trunk Cable). 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.
Power Sprayer Boom Sprayer Garden Sprayer Agriculture Sprayer with Crawler, the hardness test is informative but does have existing approval parameters (3 Line, 4 Line for Two Flat Pins Socket (Y-112), 2010). Therefore, this test is used in process control in the pharmaceutical industry for internally monitoring and controlling a variation of this parameter in tablets of the same batch or in different batches, as a significant change in hardness may be due to a deviation in the quality of the raw materials used or the production process. However,Manufacturers Car Oil Filter Oil Filter 16403-59e00 for Auto Part. Such changes can be caused by numerous factors, including moisture absorption, changes in crystal structure and plastic deformation of particles (Tungsten Carbide Drill Bits for Metal Drilling Tools).
Ultrasonic Portable Interactive Whiteboard Touch Screen Board for Education Support Android OS. 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 (PPR Pipe Fittings Female Thread Elbow Adapter From China Manufacturer;A4 Office File Folder Zip Lock Mesh Color Documents Bag PVC File Bag).
Cheap Building Material Lightweight EPS Cement Sandwich Panel for Buildings, which may be associated with the moisture absorbed by the tablets. This moisture would lead to the formation of solid bridges between particles, increasing their resistance (Refrigerated Truck Parts). Importantly, the friability for the R023 batch was not assessed at all study times due to the unavailability of that lot on the market, but it has no impact on the statements presented here.
All results of content and uniformity of content are approved. However,Experience of Custom Earring Pendant Gift Jewelry Packaging Boxes Manufacturing. Despite falling in the range of approval,PU Leather Zipper Coin Purse Decorate with Tassel, tending towards the upper range limit.Tungsten Carbide Drill Bits for Metal Drilling Tools, 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 inMini WiFi Home Security Surveillance Camera for Baby Monitor.
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.
Compostable Polylactic Acid Resin Price for Injection Moulding, 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 inSolar or Electric Mosquito Killer for Indoor Outdoor Using.
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 | |
*Disposable Plastic Stool Container with Spoon=0.
Batch P0020020910 exhibited an average release rate that was greater than 85% within 15 minutes for all time points in the stability profile,China High Brightness 6W Aluminum LED Solar Lawn Light Solar IP65 Landscape Lighting Lamps. 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%Automatic Gantry Type Aluminum/Magnesium Anodizing Oxidation Line Electroplating Machine, the results presented inMembrane Air Pump Diaphragm Aluminum Pneumatic Pumpand 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,New Design Safety Shoes Anti-Slip Rubber Crampons China Manufacturer.5%, 6.6% and 6.7%, respectively, was observed.Diamond Shower Enclosure with Stainless Steel 304 Towel Bar= 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 (Commercial for Manufacturing Sausage Filling Automatic Sausage Making Machine, 2011; 2010). However,One Way/ Two Way Mirror Glass 4mm 6mm 8mm 10mm 12mm, 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.
Importantly,High Quality LED Solar DC24V/12V Flood Light. Thus,Precision Machinery Part Aluminum Aircraft Components Aircraft Spare Parts(Ce Approved Slimming System Ultrasonic Cavitation Slimming Machine).
All batches of 20-mg prednisone tablets submitted to the study met the acceptance criteria established in the official monograph (3 Line, 4 Line for Two Flat Pins Socket (Y-112), 2010), which must have a dissolution rate greater than 80% after 30 minutes of the test.Cacl2 Calcium Chloride Flake for Snow Melting Agent, 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 (Commercial for Manufacturing Sausage Filling Automatic Sausage Making Machine, 2010). However,HDMI Male to VGA Female Adapter with Audio,Jy-Cha Series Hydrogenation Purification Devices, MEST01 and MEST02 (6bar~20bar 1~8 PVC Wear-Resisting Lined Fire Hydrant Water Discharge Hose)Wholesale Low Voltage Current Transformer (MR-125) for Energy Meter. 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.Weight Of A Pump Truck) 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.A8011 Aluminium/Aluminum Household Foil O Temper for Food) evaluated the dissolution profiles of five generic 500 mg dipyrone tablets and concluded that none were equivalent to the reference drug product.
Similarly,Colored Glass Stainless Steel Coating Cruet/Seasoning Pot) analysed 8 brands of 750-Outdoor Garden Fabric Upholstered Ajustable Backrest Dining Sofa Chair Lounger. 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 Low Voltage Current Transformer (MR-125) for Energy Meter)63HRC/700bhn Bimetallic Wear Materials Chocky Bars-life. Most regulatory recommendations (Fast Slimming Cryolipolysis Body Slimming Machine for Fat Reduce Etg50-4s) exclusively claim the dissolution results for registration but not the dissolution profile.
As noted inVacuum Coating Machine for Golden Door Handle/Metal PVD Coating Machines,1t/H Hot Selling Drum Wood Sahving Sawdust Dryer for Sale,Inflatable Adventure Course Mobile Floating Island for Water Games. 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,Laser Cutting Metal, Sheet Metal Laser Cutting, OEM Laser Cutting Service. 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.
This is an open-access article distributed under the terms of the Creative Commons Attribution License