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Youpuhui has always adhered to the concept of intimate, high-quality, professional service to our customers, and strive to solve the difficulties and doubts encountered in the use of products for customers, this Q&A is one of the suppliers of SPI company about product Q&A, for the reference of our customers, hope to bring effective inspiration
to your daily work to solve problems.
of SPI are recommended for direct pressure process.
SPI mannitol has advantages in formulation stability due to its low reactivity and low reducing sugar residue, which minimizes the Maillard reaction of APIs or excipients containing amines with reducing sugars
.
.
.
to your daily work to solve problems.
Q&A 1
Q: When using softgels made of sorbitan sorbitan solution, what excipients can be added to make the softgels disintegrate quickly after long-term storage?
Answer: It is difficult to prevent the aging of soft capsules after long-term placement, and the effect of simply adding excipients is not ideal, you can try to add citric acid and docusate sodium to the rubber skin solution
.
Q&A 2
Q: What is the function of 1,4-dehydrate-D-gluconol in the composition of sorbitan sorbitan solution?
Answer: 1,4-Dehydrated-D-gluconol has a rigid molecular structure and a wide melting point range, as a copolymer modified material, it can improve the mechanical properties of the copolymer, the glass transition temperature and the transparency
.
Q&A 3
Q: How does sorbitol sorbitan solution reduce the probability of crystallization of softgel capsule capsult?
Answer: It can be seen from the structure of sorbitol that sorbitol molecules contain a large number of hydroxyl groups, which have strong hydrophilicity, can effectively lock water, prevent water dispersion loss, and greatly reduce the migration of water in the capsule shell while plasticizing, thereby reducing the probability
of crystallization of soft capsule shell due to water dispersion loss.
Q&A 4
Q: The limits of ethylene glycol and diethylene glycol under the identification item in the internal control standard of sorbitol sorbitan solution are controlled by 0.
10%, why is ethylene glycol separately controlled again in the standard, and the limit is 310ppm? And where is the source of 310ppm? A: Ethylene glycol is known to be a residual solvent impurity produced during the production of sorbitan sorbitan solution
。 Because the product is a sugar alcohol, it is possible to produce ethylene glycol
during the hydrogenation step in the production process.
Therefore, ethylene glycol is recommended as part of the residual solvent control strategy (ICH group II solvents), which is consistent with
the inclusion of ethylene glycol in the quality standards in the ICH Q3C residual solvent guidelines.
Its evaluation and analysis is part of
the production risk assessment.
This is the basis
for controlling ethylene glycol in SPI's quality standards.
Q&A 5
Q: What method is used to calculate the content of sorbitol sorbitol special®A-810 in sorbitol glycerol premix?
A: The calculation is carried out using the external standard method
.
Q&A 6
Q: Sorbitol sorbitan glycerol premix Sorbitol Special®A-810 registration standard does not identify this test, what is the reason?
A: Sorbitol Sorbitol Special®A810 is a premix of sorbitol sorbitan solution NF and glycerol, so there is no discriminator
.
Whether to set the identification of sorbitan sorbitan, the customer can evaluate by himself, and the identification method of sorbitan sorbitan solution NF is applicable
.
Q&A Seven
Q: What is the maximum safe daily dosage of sorbitan sorbitan solution when applied in capsule shells? Can I find it in the FDA's IIG limits?
A: The maximum safe amount of Sorbitol Special®NF and MDF85 in capsule shell is 501mg, which can be queried
in FDA IIG using "SORBITOL SPECIAL POLYOL SOLUTION" 。 THE MAXIMUM SAFE AMOUNT OF SORBITAN GLYCERIN A-810 FOR APPLICATION IN CAPSULE SHELLS IS 2767 MG, WHICH CAN BE FOUND
IN FDA IIG USING "SORBITOL-GLYCERIN BLEND".
Q&A 8
Q: When developing softgel formulations, when using PEG as filler and glycerol or sorbitol as plasticizer, there will be problems such as migration, delayed softgel disintegration, capsule rupture, etc.
, how to solve them?
A: It is recommended to use Sorbitol® Special series of sorbitol sorbitan solution, because it is insoluble in PEG, it will not penetrate into the PEG filling solution of the capsule and migrate, and can also reduce the drying time by up to 45%, adjust the moisture content of the capsule shell, and avoid the capsule rupture
.
Q&A 9
Q: In formulation development, some APIs or excipients containing amines will react with reducing sugars resulting in poor stability, how to choose a suitable diluent?
Answer: Mannogem®Emerald and Onyx are recommended for granulation process, and other mannitol modelsof SPI are recommended for direct pressure process.
SPI mannitol has advantages in formulation stability due to its low reactivity and low reducing sugar residue, which minimizes the Maillard reaction of APIs or excipients containing amines with reducing sugars
.
Q&A 10
Q: Why is the detection of sorbitol in the Mannogem®XL quality standard for the detection of sorbitol, and is there no mannitol reference solution? Answer: There is no separate preparation of mannitol reference solution, but there is preparation of sorbitol reference solution, sorbitol and mannitol mixed solution; Because the sorbitol reference solution alone can determine which of the sorbitol peaks is in the spectrum of the mixed sorbitol and mannitol solution.
Q&A Eleven
Q: Why is SPI mannitol calculated using sorbitol peak area as a standard compared to all other impurities? A: Because mannitol is produced by chemical synthesis, there are trace amounts of sorbitol in the product, sorbitol is an isomer of mannitol and an epimer, the chemical method used by the Chinese pharmacopoeia to detect is indistinguishable from mannitol and sorbitol, while the United States and Europe are using HPLC detection to isolate and control.
Q&A 12
Q: How to solve the problem when developing functional coated (TM or MUPS) API formulations using fine-size, low-density spray-dried mannitol, which has poor mixing uniformity and low compression performance?
A: Mannogem®XL Ruby has coarse particle size and high density performance, which can be closely combined with TM and MUPS (multi-element microcapsule system) API to mix more uniformly, improve content uniformity, and avoid delamination; The increase in tensile strength improves the protection
of the coating API during preparation.
Q&A XIII
Q: In R&D and production, which model of mannitol is recommended for the preparation of preparations with high drug load and small size, high hardness and fast disintegration? Answer: It is recommended to use mannitol Mannogem®XL Opal and XL Ruby, which have high compressibility, high drug load, fast disintegration, low brittleness, good taste, can press out tablets with qualified hardness under various pressures, the dosage is smaller, and the cost is reduced
.
XL Opal has the best
compressibility.
Q&A 14
Q: The preparation of effervescent tablets often occurs sticky, moisture absorption, etc.
, and the packaging requirements are strict, strictly prevent moisture absorption, resulting in difficult production process and high cost, how to solve it?
Answer: It is recommended to use surface modified sodium bicarbonate Effer-Soda®12, which is a sodium bicarbonate containing 10~17% sodium carbonate after surface processing, which can prevent the sticking problem of effervescent tablets in the preparation process, and also well avoid quality problems
such as rising bags caused by early moisture absorption of effervescent agent to produce carbon dioxide.
Q&A 15
Q: In the development of oral disintegration preparations for children (oral disintegration microtablets), it is necessary to select excipients with good fluidity, compressibility and low oral wettability for direct tablet compression, recommend a suitable excipient?
A: It is recommended to use Pharmaburst®500, a co-treatment of mannitol cross-polymer wheat mountain, which has high compressibility, fluidity, fast disintegration, low brittleness, improves patient compliance and reduces development time, and is a co-treatment excipient
specially designed for oral collapsing tablets.
