MANUFACTURER IN CHINA
Bluslot is a professional manufacturer whose main products include: dissolution sinker, dissolution basket, capsule sinker, paddle, paddle over disk, etc.
- Brand: BLUslot
- Material: SS316
- D/L/S: 25.4mm / 34.925mm / 25-150rpm
- Mesh size: 10, 20, 40, 100, 150.
- Advantage: Special production process, no welding is required
Bluslot can also customize mini baskets and special baskets for specific new drugs.
Dissolution Basket：Since 1970, the dissolution test method proposed for the first time a method of dissolving drugs using a rotating basket as a container. The necessary part is a 40-mesh wire-diameter basket made of a stainless steel basket with a diameter of 25.4mm and a length of 34.925mm. The dissolution of the drug is carried out at 25-150 rpm, which we call method 1 (Apparatus 1).
After years of practice and development, the current baskets present a variety of styles and specifications.
The core problem of the dissolution basket method is how to provide a suitable mesh size to ensure that different drugs can be fully dissolved in the basket.
BLUslot can not only provide a wide range of mesh options but also can make baskets with special shapes and pores. We can also customize special-shaped carousel products of various shapes, which can be matched with a variety of different drugs.
Advantages of Bluslot dissolution basket
- High-quality raw materials and low prices.
- The special splicing process requires no welding, and the structure is firm and durable.
- 10,20,40,80,100 mesh products are in stock all year round and shipped within 3 days.
- The mesh of the basket body is uniform, meeting the requirements of <711>.
- Free basket tools. Reduce the touch of the basket.
- Provide customized services of various specifications.
In the drug dissolution experiment, the floating capsule tablet can not guarantee its dissolution rate.
USP 711 states that a small, loose, nonactive metal material can be used in some floating agents, such as spiral coils.
The dissolution sinker can be reproduced by placing it at a certain point. Similarly, for settling devices, it can be applied to tablets that are easier to stick to the dissolution cup.
When conducting drug research and development test, the dissolution sinker will be used to load the tablet or capsule into the prescribed settling device.
It is made of 316L stainless steel with better corrosion resistance.
In line with the provisions of the United States Pharmacopoeia, a small cup dissolution test is applicable, anti-corrosion, suitable for a variety of acid, alkali, and other corrosive media, resistant to general acid-base, and organic corrosion.
High strength, good toughness, suitable for the high-pressure environment, weldable, easy to load and unload, stable pass, uniform distribution, good regeneration performance, after repeated cleaning and regeneration, the filtration performance recovers more than 90%.
Dissolution Basket Product Catalog
|10 Mesh Basket, Standard Push-On Style, 316 SS, Serialized
|10 Mesh Basket, Evolution Style, 316 SS, Serialized
|20 Mesh Basket, Standard Push-On Style, 316 SS, Serialized
|20 Mesh Basket, Evolution Style, 316 SS, Serialized
|40 Mesh (USP) Basket, Standard Push-On Style, 316 SS, Serialized
|40 Mesh (USP) Basket, Evolution Style, 316 SS, Serialized
|100 Mesh Basket, Standard Push-On Style, 316 SS, Serialized
|100 Mesh Basket, Evolution Style, 316 SS, Serialized
|40 Mesh Basket, Standard Push-On Style, PTFE Coated over 316 SS
|Suppository Basket, Plastic
|Basket Adapter Hub for Standard Push-On Style, 316 SS, Serialized
|Basket Adapter Hub for Evolution Style, 316 SS, Serialized
|Basket Clip for Evolution Style Hub, 316 SS
Dissolution Basket quality inspection
The picture below is Bluslot’s professional dissolution basket coaxiality testing equipment.
The head of the dissolution apparatus is lowered to the working position, and the measuring table is lowered into the dissolution cup with the rotating basket. It will be noted that the measuring rod of the meter should be pushed inward by hand during the descending process to avoid the collision of the measuring rod with the wall of the dissolution cup and cause damage.
When the measuring rod of the measuring table completely enters the dissolution vessel, slowly release the measuring rod. This position is the initial position for the verification of the coaxiality of the rotating basket.
Slowly turn the clutch of any basket other than the one being verified by hand. “Difference” is the difference between “** value” and “minimum value”. When the value of “difference” exceeds 2mm, the basket does not meet the verification requirements. After the basket rotates one circle, the basket rotates one circle in the reverse direction.
Verify all the baskets in turn according to the sequence of the basket position numbers, record the verification results in turn, and complete the verification of all baskets.
Precautions when using the dissolution basket
- Choose the correct mesh of baskets to avoid clogging.
- Reduce the touch of the wire mesh basket. Avoid basket deformation and contamination of the basket.
- Clean the basket after use.
- Clean the basket with an ultrasonic bath.
- Make sure the basket is dry before use.
- A professional storage box is used to prevent the basket and ensure that the basket does not shake. Bluslot has designed basket holder of different specifications.
Bluslot’s patented technology for dissolution basket
- NW product series – No welding structure
When experimenting with special chemicals, the welding place will corrode the chemicals, which will seriously affect the results of the experiment.
Bluslot is the first Chinese company to successfully develop a dissolution basket production process that does not require welding.
- The special surface treatment process
During the use of the basket, the basket body will inevitably be touched. Contaminants will remain on the basket, and bubbles will be generated during the experiment, which will affect the final result.
- The product conforms to USP, EP, and BP.
- The product meets OEM standards.
- Adaptive brand：Agilent，Caleva，Distek，Electrolab ，Erweka Hanson，Teledyne，Pharmatest，Sotax，Zymark.
Material of dissolution sinker
- The material is made of 316 stainless steel, the texture is hard, the application range is wide, the durability is good, and the life is long.
- However, sometimes the tablet is sensitive to metal or reacts with 316 SS, or when a strong corrosive solvent is easy to destroy 316 SS, you can also choose a dissolution sinker made of PTFE or PTFE coated 316 SS.
- When using a fully automatic dissolution apparatus for dosing medicine, a magnetic dissolution sinker can also be used.
Types of dissolution sinker
- Standard dissolution sinker
The most widely used type, but it is not suitable for all dosage forms, Bluslot can customize products of various specifications for users.
- Elastic spiral type
The elastic spiral type is easy to use and cost-effective. It is often used in capsules and tablets of various sizes.
The three-pronged shape has a unique appearance and is very suitable for suppositories, and also suitable for size 1-3 capsules.
The O-shaped type is composed of 316 stainless steel and O-ring, suitable for large size 0 capsules.
- Special-shaped type
The special-shaped type dissolution sinker is not widely used and is generally used in dosage forms such as tablets, capsules and patches.
Standard settling basket is the most widely used type, but it is not suitable for all dosage forms. Bluslot can customize products of various specifications for users.
How to choose dissolution sinker？
The main consideration in the selection of dissolution sinkers is the size.
- The dissolution sinker and the preparation must have a small contact area, otherwise, it will affect its dissolution rate.
- The size of the dissolution sinker should be slightly larger than that of the capsule tablet, but it will not allow the reagent to float seriously in the basket.
- The space between the spiral settling devices should be as wide as possible to avoid blockage affecting the dissolution rate.
The corresponding sizes of different types of capsules are as follows:
When the drug disintegrates into small particles in the dissolution process, and the small particles need to continue to settle the drug, the appropriate basket aperture should be selected according to the particle size.
Use and maintenance of dissolution sinker
Due to its inert and corrosion resistance, PTFE is often coated on the surface of the dissolution sinker to prevent corrosive solvent from contacting with stainless steel and prolong its service life.
However, compared with SS316, PTFE coating is more likely to fall off, so in the process of use and maintenance, it is necessary to pay attention to wash it with deionized water immediately after each use.
If detergent is needed, it is recommended to use a neutral and mild detergent. After washing, rinse it with deionized water. After washing, dry it with a soft cloth. Do not wipe the surface with force.
If heating drying is used, the temperature should not exceed 90 ℃.
Do not use ultrasonic cleaning.
Difference in vitro dissolution of two cefuroxime axetil capsules with basket sinker
Cefuroxime axetil (CEF) is a second-generation cephalosporin antibacterial drug. Used for the treatment of respiratory and urinary tract infections, gonococcal infections, etc. Its marketed preparations include tablets, capsules and other oral dosage forms. Due to its extremely poor water solubility, its raw material crystal form, prescription composition and preparation process are different. This often leads to large differences in its absorption and bioavailability in the body, thus affecting its efficacy. Currently, there are many manufacturers of CFE oral preparations. The quality of products from different manufacturers or even different batches of products from the same manufacturer varies greatly. Clinical efficacy varies. Dissolution is an evaluation of the intrinsic quality of solid preparations such as tablets and capsules. It is an important means to ensure its clinical efficacy and to control the production process of preparations. It is suitable for capsules and certain tablets.
The following are the details.
The use of a dissolution sinker can generally reduce the poor reproducibility of measurement data due to different positions of the sample during the dissolution measurement process. Then distinguish products from different manufacturers and minor differences in dissolution behavior within and between batches.
Therefore, this article will study the role of dissolution sinker in dissolution determination. It aims to provide an important basis for the scientific and reasonable formulation of quality standards for oral preparations of this drug in the future and the correct evaluation of its intrinsic quality.
Determination of dissolution of 2 different capsules.
Measured by paddle method, the volume of dissolution medium is 900 mL, the rotation speed is 50 r·min and the temperature is (37±o.s)·c. The dissolution media were hydrochloric acid solution with pH = 1.0, acetate buffer with pH = 4.5, phosphate buffer with pH = 6.8, and distilled water.
Take 6 commercially available CEF capsules A and 6 homemade CEF capsules respectively. There are two ways to use dissolution sinker or not to use dissolution sinker in the test. Operate according to the law, take a sample of 5 mL at 5, 10, 15, 20, 30, 45, and 60 minutes after starting the stirring paddle, filter it with 0.45 µm micropores, and replenish the same volume of dissolution medium at the same temperature in time. Take the continued filtrate and dilute it to an appropriate multiple with the dissolution medium, then use it as the test solution, and use the corresponding dissolution medium as a blank.
Results The dissolution curves of the two CEF capsules measured in four different dissolution media with and without the dissolution sinker are shown in Figures 1 to 4 respectively. It can be seen that commercially available CEF capsules are in the above four different dissolution media. When using the dissolution sinker, the cumulative dissolution percentage is reduced by about 25% to 50% compared with before use, and the degree of dissolution is significantly reduced.
In the dissolution determination of solid preparations, select appropriate dissolution determination conditions. It is extremely important to establish the correlation between in vitro dissolution and in vivo absorption and to distinguish the quality differences of preparation products from different sources. This article compared the dissolution rates of homemade and commercially available CEF capsules in four different dissolution media using a dissolution sinker and without a dissolution sinker. The results show that the use of dissolution sinker has almost no effect on the dissolution behavior of homemade CEF capsules. The dissolution behavior of commercially available CEF capsules in four different dissolution media was significantly affected. The dissolution rate and degree of dissolution are significantly reduced compared with those without dissolution sinker.
This is because CEF is a poorly water-soluble drug. The type, nature and dosage of excipients used in capsule prescriptions will have a significant impact on its dissolution behavior. Therefore, it can be speculated that there must be a big difference in the prescription composition of homemade CEF capsules and commercial products. The study also found that in the former, the capsule shell disintegrated faster and the contents in the capsule dispersed faster during the dissolution test. Therefore, its dissolution is less affected by the medium flow and the relative position to the stirring paddle. On the contrary, after the capsule shell of the latter disintegrates, the drug and excipients adhere to form agglomerates and stay in the dissolution sink for a long time. Therefore, its dissolution is greatly affected by the water flow and the relative position to the stirring paddle. Therefore, it can be determined that the prescription composition and preparation process of homemade CEF capsules should be more scientific and reasonable than those of commercially available products. This result also shows that in dissolution determination, the use of dissolution sinker can effectively eliminate the poor reproducibility of dissolution data caused by the uncertainty of the position of the test preparation. Therefore, small differences in quality between preparations from different manufacturers can be better distinguished.