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Method for evaluating in-vivo and in-vitro correlation of theophylline sustained-release tablets

A sustained-release tablet and correlation technology, which is applied in the field of evaluating the in vitro and in vivo correlation of theophylline sustained-release tablets, can solve the problems of not being able to evaluate the pharmacokinetic characteristics in vivo well

Inactive Publication Date: 2022-02-25
则正(上海)生物科技有限公司
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Benefits of technology

The technical effect of this patented experiment on measuring the interaction between two substances inside or outside living organisms has been explained through experiments conducted with different methods for studying these interactions. By analyzing data from both tests it can be possible to better evaluate how well certain drugs are absorbed into their bloodstreams when administered systemically (circulated pools) compared against those given intravaginally. This improves upon previous methods used during clinic trials where patients were treated differently due to differences in drug metabolism caused by factors like food consumption.

Problems solved by technology

This patents discusses how therapeutic agents like beta blockers may help reduce respiratory issues associated with asthms due to their short time onset, inconvenience during use, stability under different conditions, and potential side effects from other medications currently available. However current evaluating techniques lack sufficient accuracy when studying these compounds at this stage because they only examine one aspect of them individually instead of integrally across multiple aspects involved.

Method used

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  • Method for evaluating in-vivo and in-vitro correlation of theophylline sustained-release tablets
  • Method for evaluating in-vivo and in-vitro correlation of theophylline sustained-release tablets
  • Method for evaluating in-vivo and in-vitro correlation of theophylline sustained-release tablets

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Experimental program
Comparison scheme
Effect test

Embodiment 2

[0043] Embodiment 2 The changes of theophylline sustained-release tablets observed by contrasting the disintegration phenomenon of theophylline sustained-release tablets in pH4.5+pH6.0-xanthan gum+glass beads medium by comparing different prescriptions. The formulations of different batches of self-developed preparations are HQ-0005-21082301 (20% EC+3.5% lactose) medium containing 1% xanthan gum, HQ-0005-21090701 (20% EC+5% lactose) medium containing 1 % Xanthan gum, HQ-0005-21080901-02 (20% EC+7.5% lactose) medium containing 1% xanthan gum, pilot product 21012401 batch (mid-term) medium containing 1% xanthan gum, HQ-0005-21060902 (EC dosage 30%) The medium contains 1% xanthan gum. When 1% xanthan gum is added to the glass bead medium (pH4.5, pH6.0), the HPMC prescription self-developed preparation has a greater degree of softening and abrasion, while other EC and EC+lactose self-developed preparations basically have no Variety.

Embodiment 3

[0044] Embodiment 3 by contrasting the release properties of theophylline sustained-release tablets of different prescriptions, such as image 3Shown, the release performance of theophylline sustained-release tablets in pH4.5+pH6.0 medium using USP III method. The formulations of different batches of self-developed preparations are HQ-0005-21060902-01 (30% EC), 21012401 (HMPC), HQ-0005-21080901-02 (20% EC+7.5% Lactose), HQ-0005- 21090701 (20% EC+5% Lactose), HQ-0005-21082301 (20% EC+3.5% Lactose), RLD 89A26P. By comparing the dissolution curves of the self-developed preparations of different prescriptions in pH4.5+pH6.0 media, the dissolution curves of the self-developed preparations formulated by HPMC are closest to those of the reference preparation (pre-BE results show that Cmax is on the high side); 20% EC The dissolution curve of the self-developed preparation with +5% Lactose prescription is relatively close to that of the reference preparation.

Embodiment 4

[0045] Embodiment 4 by contrasting the release properties of theophylline sustained-release tablets of different prescriptions, such as Figure 4 Shown, the release performance of theophylline sustained-release tablets in pH4.5+pH6.0 medium by flow cell method. The formulations of different batches of self-developed preparations are HQ-0005-21060902-01 (30% EC), 21012401 (HMPC), HQ-0005-21080901-02 (20% EC+7.5% Lactose), HQ-0005- 21090701 (20% EC+5% Lactose), HQ-0005-21082301 (20% EC+3.5% Lactose), RLD 89A26P. By comparing the dissolution curves of self-developed preparations with different prescriptions in pH4.5+pH6.0 media, the results showed little difference, but there was a big difference with the reference preparation.

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Abstract

The invention relates to a method for evaluating in-vivo and in-vitro correlation of theophylline sustained-release tablets. The method is characterized in that different batches of theophylline sustained-release tablets are detected by using a flow cell method and a disintegration phenomenon observation method. The theophylline sustained-release tablet is prepared by the following steps: performing wet granulation on theophylline and ethyl cellulose (adopting absolute ethyl alcohol as a wetting agent), then adding other auxiliary materials, mixing, and tabletting. The theophylline sustained-release tablets are theophylline sustained-release tablets formed by an optimized EC dosage prescription and theophylline sustained-release tablets formed by an optimized lactose dosage prescription.

Description

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Claims

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Application Information

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Owner 则正(上海)生物科技有限公司
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