The pharmaceutical industry is highly research and development (R&D) intensive, on average spending 17% of the revenues on R&D yearly. The success of major drug companies is almost wholly dependent upon the discovery and development of new medicines.
A good quality can cost less: Drug R&D
The pharmaceutical industry is highly research and development (R&D) intensive, on average spending 17% of the revenues on R&D yearly. The success of major drug companies is almost wholly dependent upon the discovery and development of new medicines.
Pharmaceutical manufacturing required a highly controlled and regulated environment. Manufacturers need to automate almost every process and there is a piece of pharmaceutical manufacturing equipment involved in every process. Drug manufacturing is the process of industrial-scale production of pharmaceutical drugs by pharmaceutical companies. The drug manufacture can be broken down into a series of unit operations, including milling, mixing, filling, granulation, coating, tablet pressing, and other processes, which required different equipment as shown in Table 1. Figure 1 shows the pharmaceutical manufacturing process for the dosage-form products such as tablets, pills, and capsules.
Table 1: Examples of pharmaceutical manufacturing equipment and process
Equipment
Process
Description
Granulators
Granulation
For preparations into powders or granules.
Mixers
Mixing
For blending and particle size reduction
Fillers
Filling
For filling samples into capsules or container
Tablet press
Tablet pressing/ compression
For producing tablets.
Coaters
Sugar coating
To coat tablets or capsules with films like a sugar film.
Millers
Milling
For breaking down coarse particles into finer ones
Figure 1: Pharmaceutical manufacturing of dosage-form products (Credit to Encyclopedia of occupational health and safety 4th edition)
Validating and optimizing the manufacturing process during R&D is necessary to ensure the quality of the product while reducing the cost and improve the process efficiency. All-purpose equipment that can carry out most of the pharmaceutical manufacturing process will ideal for R&D. ERWEKA is one of the leading international manufacturers of test equipment for the pharmaceutical industry. ERWEKA offered an all-purpose solution for small-scale production in the pharmaceutical, chemical, cosmetic, and food industries, fits perfectly into R&D of powder tablets, ointments, creams, and more. The modular design is compact, economical and comes with a powerful AR 403 motor drive unit with a wide range of easily interchangeable attachments for various purposes: stirring, kneading, mixing, granulating, coating, polishing, milling, sieving, filling, dosing. Such modular method offers economical capital cost (one drive, many attachments) while ensuring constant product quality (improving production). Figure 2 illustrated the drive unit AR 403 along with various interchangeable attachments.
Figure 2: The ERWEKA’s All-Purpose equipment driving by unit AR 403 (Right). The various attachments can be easily and quickly connected through coupling to AR 403 such as ERWEKA SW 1/S – Laboratory High Speed Mixer, ERWEKA GTE – Pelletizer, ERWEKA KB – Cube Mixer, and ERWEKA TG 2000 – Double Roll Crusher (Left, from top to bottom).
Pharmacopoeia as quality codex of Pharmaceutical: Drug Quality Control (QC)
To ensure appropriate quality standards for excipients, drug substances, and drug products, United States Pharmacopeia (USP), European Pharmacopoeia (EP), Japanese Pharmacopoeia (JP) and other pharmacopoeia established pharmaceutical standards in their country. USP sets quality, purity, strength, and identity standards for medicines, food ingredients, and dietary supplements. Today, USP reference standards and monographs are legally recognized in the U.S. and relied upon more than 140 countries including Malaysia and Singapore.
Manufacturers test their products against pharmacopeia standards to ensure they meet published specifications. Regulatory agencies use these standards to help to ensure the products are of the appropriate identity, as well as strength, quality, purity, and consistency. Today, a drug can only go into the market if only it passes several quality control tests as specified in pharmacopeia including dissolution test, disintegration time test, uniformity of weight test, uniformity of content test, etc.
Figure 3: 7 types of methods for dissolution testing according to USP general chapters <711>.
Dissolution testing is used to characterize the dissolution properties of the active drug. Dissolution testing measures the amount of time required for a given percentage of the drug substance in a tablet to go into solution under a specified set of conditions. Different dissolution testing methods are described in USP, EP, JP, and other internationally harmonized Pharmacopeia. USP recommends 7 types of methods using basket (USP1), paddle (USP2), and others as shown in Figure 3.
Automation in the pharmaceutical industry is becoming increasingly important to the continued success and competitiveness of pharmaceutical manufacturers to faster quality inspection. The new ERWEKA DT 950 Series (Figure 4a) is the first digital dissolution tester, equipped with the most advanced embedded PC technology for the requirements of today and the challenges of tomorrow. Besides 100% USP/EP/JP compliant, DT950 is equipped with groundbreaking embedded PC technology, a 7" touch display with an advanced, easy-to-use interface, the intelligent Test Assist for simple error-proof testing, and an unprecedented upgradeability. The new design and high degree of modularity mean that, for example, a 6-station stand-alone DT 956 can be easily transformed into the heart of a complete Dissolution HPLC On-/Offline system with 8 test stations and Disso.NET 4 software.
A disintegration test is provided to determine whether tablets or capsules disintegrate within the prescribed time when placed in a liquid medium at the experimental conditions according to pharmacopeias. ZT 720 series automated disintegration tester (Figure 4b) is developed by ERWEKA to automatically determines the disintegration time of samples by using a unique system of magnets and sensors. It also tests whether a sample is completely disintegrated automatically.
Even the high initial cost of the automated system, the automated dissolution and disintegration tester are attractive to pharmaceutical, attributed to the increased productivity by expediting the drug QC process while guaranteeing accurate results.
(a)
(b)
Figure 4 (a) The digital dissolution tester ERWEKA DT 950 series and (b) ERWEKA ZT 720 series automated disintegration tester builds for automation of dissolution and disintegration test according to standard described in pharmacopeias.
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The pharmaceutical industry is highly research and development (R&D) intensive, on average spending 17% of the revenues on R&D yearly. The success of major drug companies is almost wholly dependent upon the discovery and development of new medicines.
A good quality can cost less: Drug R&D
The pharmaceutical industry is highly research and development (R&D) intensive, on average spending 17% of the revenues on R&D yearly. The success of major drug companies is almost wholly dependent upon the discovery and development of new medicines.
Pharmaceutical manufacturing required a highly controlled and regulated environment. Manufacturers need to automate almost every process and there is a piece of pharmaceutical manufacturing equipment involved in every process. Drug manufacturing is the process of industrial-scale production of pharmaceutical drugs by pharmaceutical companies. The drug manufacture can be broken down into a series of unit operations, including milling, mixing, filling, granulation, coating, tablet pressing, and other processes, which required different equipment as shown in Table 1. Figure 1 shows the pharmaceutical manufacturing process for the dosage-form products such as tablets, pills, and capsules.
Table 1: Examples of pharmaceutical manufacturing equipment and process
Figure 1: Pharmaceutical manufacturing of dosage-form products (Credit to Encyclopedia of occupational health and safety 4th edition)
Validating and optimizing the manufacturing process during R&D is necessary to ensure the quality of the product while reducing the cost and improve the process efficiency. All-purpose equipment that can carry out most of the pharmaceutical manufacturing process will ideal for R&D. ERWEKA is one of the leading international manufacturers of test equipment for the pharmaceutical industry. ERWEKA offered an all-purpose solution for small-scale production in the pharmaceutical, chemical, cosmetic, and food industries, fits perfectly into R&D of powder tablets, ointments, creams, and more. The modular design is compact, economical and comes with a powerful AR 403 motor drive unit with a wide range of easily interchangeable attachments for various purposes: stirring, kneading, mixing, granulating, coating, polishing, milling, sieving, filling, dosing. Such modular method offers economical capital cost (one drive, many attachments) while ensuring constant product quality (improving production). Figure 2 illustrated the drive unit AR 403 along with various interchangeable attachments.
Figure 2: The ERWEKA’s All-Purpose equipment driving by unit AR 403 (Right). The various attachments can be easily and quickly connected through coupling to AR 403 such as ERWEKA SW 1/S – Laboratory High Speed Mixer, ERWEKA GTE – Pelletizer, ERWEKA KB – Cube Mixer, and ERWEKA TG 2000 – Double Roll Crusher (Left, from top to bottom).
Pharmacopoeia as quality codex of Pharmaceutical: Drug Quality Control (QC)
To ensure appropriate quality standards for excipients, drug substances, and drug products, United States Pharmacopeia (USP), European Pharmacopoeia (EP), Japanese Pharmacopoeia (JP) and other pharmacopoeia established pharmaceutical standards in their country. USP sets quality, purity, strength, and identity standards for medicines, food ingredients, and dietary supplements. Today, USP reference standards and monographs are legally recognized in the U.S. and relied upon more than 140 countries including Malaysia and Singapore.
Manufacturers test their products against pharmacopeia standards to ensure they meet published specifications. Regulatory agencies use these standards to help to ensure the products are of the appropriate identity, as well as strength, quality, purity, and consistency. Today, a drug can only go into the market if only it passes several quality control tests as specified in pharmacopeia including dissolution test, disintegration time test, uniformity of weight test, uniformity of content test, etc.
Figure 3: 7 types of methods for dissolution testing according to USP general chapters <711>.
Dissolution testing is used to characterize the dissolution properties of the active drug. Dissolution testing measures the amount of time required for a given percentage of the drug substance in a tablet to go into solution under a specified set of conditions. Different dissolution testing methods are described in USP, EP, JP, and other internationally harmonized Pharmacopeia. USP recommends 7 types of methods using basket (USP1), paddle (USP2), and others as shown in Figure 3.
Automation in the pharmaceutical industry is becoming increasingly important to the continued success and competitiveness of pharmaceutical manufacturers to faster quality inspection. The new ERWEKA DT 950 Series (Figure 4a) is the first digital dissolution tester, equipped with the most advanced embedded PC technology for the requirements of today and the challenges of tomorrow. Besides 100% USP/EP/JP compliant, DT950 is equipped with groundbreaking embedded PC technology, a 7" touch display with an advanced, easy-to-use interface, the intelligent Test Assist for simple error-proof testing, and an unprecedented upgradeability. The new design and high degree of modularity mean that, for example, a 6-station stand-alone DT 956 can be easily transformed into the heart of a complete Dissolution HPLC On-/Offline system with 8 test stations and Disso.NET 4 software.
A disintegration test is provided to determine whether tablets or capsules disintegrate within the prescribed time when placed in a liquid medium at the experimental conditions according to pharmacopeias. ZT 720 series automated disintegration tester (Figure 4b) is developed by ERWEKA to automatically determines the disintegration time of samples by using a unique system of magnets and sensors. It also tests whether a sample is completely disintegrated automatically.
Even the high initial cost of the automated system, the automated dissolution and disintegration tester are attractive to pharmaceutical, attributed to the increased productivity by expediting the drug QC process while guaranteeing accurate results.
(a)
(b)
Figure 4 (a) The digital dissolution tester ERWEKA DT 950 series and (b) ERWEKA ZT 720 series automated disintegration tester builds for automation of dissolution and disintegration test according to standard described in pharmacopeias.
Additional Resources
http://www.ilocis.org/documents/chpt79e.htm
https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/revisions/m99470-gc_711.pdf
https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/generalChapter701.pdf
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