Pharmaceutical capsules are a solid formation of drug dosage. Here, the drug formulation is in a powder formation. It could be a solution or suspension, a combination of miscible liquid enclosed in a shell. The shell gets produced with gelatin, and can be hard or soft.
Capsule types – The hard gelatin capsules are for enclosing the powder or solid fills. The soft gelatin capsules are for encapsulating semisolid or liquid fillings. In fact, hard capsules are also apt for liquid or semisolid fills.
During the manufacturing steps of capsule development and filling process, quality tests play a critical role. There is more than one quality control test that needs to be performed. It is essential to comply with the standards. It is vital to meet the industrial requirements, as mentioned in the globally-accepted norms and conventional requirements. These are norms established by the pharma industry over the years. The tests could be categorized into three types – in-process testing, finished product testing, and shelf-life testing.
QC testing for capsules during the manufacturing phase – An overview
The in-process quality control testing process for capsule drug products is an integral part of industrial operations. These tests get carried out at predefined intervals. It may be during any phase of the product manufacturing process. It gets conducted by the manufacturing professionals, and they store the test results on the batch record. If there are any mismatches or adverse findings in these tests, there may be an issue. Thus, it is critical to follow the best manufacturing-process parameters.
In the encapsulation process of soft gelatin capsules, these parameters are critical to monitor –
- Ensure a uniform thickness in the gel
- The gel should be tender with optimal seal thickness during encapsulation
- The weight of the capsule fill varies from capsule-to-capsule
- The weight of the capsule shell varies from capsule-to-capsule
- The moisture level of the capsule shell before and after drying needs consideration
One must focus on visual inspection, filling weight, and uniformity for the hard and soft gelatin capsules.
QC testing for capsules after production – Critical factors to review
Manufactured pharmaceutical capsules need to undergo several QC tests. It is critical for meeting the compendial standards and regulatory norms for the industrially-accepted unit dosage capsules and similar products. This series of tests certifies whether the batch is apt for marketing and effective for the consumers.
Checking the effectiveness – Seal and permeability
In the case of soft gelatin capsules, the testers focus on physical integrity. Primarily, it depends on the overall making, certifying the absence of leakage through visual inspection. In contrast, the hard gelatin capsules get tested for breakage or opened caps on the body. The physical deformations are dissimilar, but the impact is equally damaging.
Checking the safety – Impurity and potency
All capsules get tested for drug potency. It is essential to match the mentioned percentage on the label. Apart from reviewing the products, most drug products get tested for impurities. As these are life-saving drugs with a high impact on health, it is critical to review them. The test reports must meet the predefined norms of batch acceptability.
Checking the dimension and weight
The uniformity of capsule dosage gets determined through weight variation.
- In the weight variation test for hard gelatin capsules, the tester uses ten hard gelatin capsules. These get weighed independently. After that, the drug components are eliminated from the capsule. The empty shells are weighed again, and the net weight gets calculated through subtraction.
- In the case of the weight variation test for soft gelatin capsules, the gross weight of 10 sample gelatin capsules is taken. After this, each capsule is opened with a cutting tool. It could be a blade or a scissor. The encapsulated contents get removed through washing. The washing solvent needs to get evaporated at room temperature for at least 30 minutes. The weight of the individual washed shells are further taken and calculated, obtaining the accurate content of the active ingredient.
Checking the quality and uniformity of the capsule
It is an integral test performed with specified content in the capsule. The readings are taken into consideration in the individual monographs if the capsule’s weight fails the variation test. If the weight of the capsules is perfect and uniform, there is no need to take the test. The additional tests are essential for manufacturing the capsules for adverse situations. If two or three dosage units in the batch do not meet the desired range additional testing for uniformity becomes indispensable.
Comprehensive testing for capsules – Get real-time reports.
The stability testing mechanism for drugs and capsules offers a real-time solution with the ready data of a drug component or product in the specified period. The data gets recorded under the influence of more than one environmental factor. It includes temperature, humidity, and exposure to light for long-term, short-term, intermediate, or accelerated storage conditions. The real-time data helps regulate and validate the shelf life of these capsules and pharmaceutical products. It helps match the information present on the labeled specifications under recommended storage conditions.
Essentiality of proper physical testing for capsules
Physical testing is the monitoring of the physical traits of capsules and drug components. The testing process could be distinguished into microscopic and macroscopic features.
- At the microscopic level, the sound structure of the particles gets measured through dynamic light scattering. It impacts particle absorption, dissolution, and content uniformity.
- At the macroscopic level, the oral capsules are the prime components. Macroscopic physical testing reviews the physical characteristics of the drug.
It could be the dissolution strength, disintegration, flowability of the powder, liquid viscosity, capsule dimensions, etc. These physical testing steps get performed on the raw materials during the intermediate production steps.
The lab facilities – It makes a difference. The reliability of the lab reports makes a significant impact on the effectiveness of the capsule. The disintegration of the capsule components, physical testing, and potency checks are equally critical in the manufacturing process. Make a wise choice by selecting IRCLASS Systems and Solutions Pvt Ltd (ISSPL) laboratory. It brings a one-stop solution for capsule manufacturers and enhances the quality of operations in the pharmaceutical industry. With the best-in-class facilities and quality testing measures, ensure the accuracy of the reports.