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Method for preparing pharmaceutical product

A technology for preparing drugs and drug products, applied in the concept of engineering and manufacturing, in the field of preparing drug products, to achieve the effect of simplifying development and manufacturing

Pending Publication Date: 2020-05-15
NOVARTIS AG
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, there are challenges in achieving a consistent fill volume, especially at low fill weights, of neat API into capsules

Method used

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  • Method for preparing pharmaceutical product
  • Method for preparing pharmaceutical product
  • Method for preparing pharmaceutical product

Examples

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example 1

[0263] From early in the development lifecycle of such compounds, pharmaceutical drug products containing LEE011 will need to be manufactured in large quantities. With the equipment platform described here, several batches of API were crystallized, sieved and filled into capsules using two types of vacuum tumbler equipment: standard filler and sonic filler. The filling performance of most used powder variants is good enough especially with regard to dose uniformity (dose range from 10 to 250 mg), however, on average, the powder behavior / flowability in the machine hopper and when moving between parts The friction generation presents a challenge, causing certain problems and process downtime over long runtimes. Standard filling techniques (especially after some optimization) can cope with such inherent difficulties associated with LEE011 powder (successfully filling millions of capsule units), while sonic filling techniques have shown process downtime and Significant event of c...

example 2

[0265] Filling net drug substance at a certain yield (suitable for high-volume manufacturing) is not generally well established in the industry. For API LXS196, the particle characteristics and filling process were developed in an integrated manner. The described method enables the manufacture of LXS196 capsules for clinical supply with a yield of better than 40'000 capsules within 6 hours. The percentage of good capsules was 98.8% of the total number of capsules produced. A simplified manufacturing process is achieved, with only sieving and packaging of net drug substances performed (including 100% weight control via capacitive sensors, dedusting and metal inspection). Also, doses up to 400 mg are filled into size 0 capsules. In addition, doses above 450 mg are packaged on automatic drum-fill equipment using an in-house developed high-dose technology (tapping mechanism).

example 3

[0267] Dosing of the powder containing sub-milligram quantities of the API was done at the cut edge of the capsule fill. To overcome the challenges, in the development of galenicals, the standard process for low-dose formulations describes blending and diluting the API with excipients in several blending steps, which allows a few milligrams of the diluted The blend is finally dosed into capsules. The same is true for machines equipped with capacitive sensors for quality checks typically used for capsule filling starting at a minimum of a few milligrams and above.

[0268] The method described herein allows the processing of a net API of FTY720 containing less than 1 % additives (API>99%), with optimal physical properties, suitable for precise capsule filling at very low doses (eg 0.5mg and 0.25mg).

[0269] Furthermore, the method of the present disclosure presents a very simple process compared to current commercially available formulations where multiple process steps are ...

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Abstract

A method of preparing a pharmaceutical product comprises the steps of (a) providing a neat active pharmaceutical ingredient (API) which complies with at least five of the following parameters (i)-(viii) as determined by using a FT4 powder rheometer: (i) specific basic flow energy (sBFE) of at most 60 mJ / g; (ii) stability index (SI) of 0.75 to 1.25; (iii) specific energy (SE) of at most 10 mJ / g; (iv) major principle stress at 15 kPa (MPS-15) of at most 40; (v) flow function at 15 kPa (FF-15) of at least 1.3; (vi) consolidated bulk density at 15 kPa (CBD-15) of at least 0.26 g / mL; (vii) compressibility of at most 47 %; and (viii) wall friction angle (WFA) of at most 40 degrees; (b) dispensing the neat API of step (a) into a bottom part of a pharmaceutical carrier using a vacuum assisted metering and filling device; and (c) encapsulating the bottom part of the pharmaceutical carrier with a complementary lid part of the pharmaceutical carrier, thereby producing a pharmaceutical product.

Description

[0001] The present invention relates to a process for the preparation of a pharmaceutical product comprising filling an active pharmaceutical ingredient powder into a pharmaceutical carrier with a vacuum assisted metering and filling device. The methods disclosed herein can be used in continuous processes, such as high throughput processes for the production of pharmaceutical products. Background technique [0002] Formulating active pharmaceutical ingredients (APIs) from discovery through early clinical all the way to late clinical to final commercial product is demanding and resource intensive. Commercial formulations and related manufacturing processes containing APIs typically involve excipient blending or granulation. Geometric dilution, wet granulation and dry blending are especially useful for the manufacture of low dose formulations. A lot of effort goes into achieving a proper blending method to ensure dosage uniformity and homogeneity between excipients and API. In...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K9/48A61K31/137A61K31/454A61K31/498A61K31/519
CPCA61K9/4833A61K31/137A61K31/454A61K31/498A61K31/519A61J3/02A61J3/074A61K9/0053A61J2200/70B65D43/0212
Inventor N·拉塞纳克J·奥戈尔卡M·克鲁姆S·朗P·特里施勒S·施泰格米勒G·斯托特D·博洛格J·帕克斯F·韦伯H·施耐德M·莫拉托E·迪伦佐D·胡克
Owner NOVARTIS AG