Introduction

Oral Solid Dosage Manufacturer based in Vapi, Gujarat, India
Oral Solid Dosage Manufacturer based in Vapi, Gujarat, India

In the realm of pharmaceutical manufacturing, the winds of change are blowing stronger than ever. Even before the unprecedented upheaval brought on by the COVID-19 pandemic, companies had been gradually shifting away from in-house tablet coating formulations in favor of more efficient, fully Automated film coatings. In this article, we explore why this transition to a leaner system is gaining momentum and why it’s the right time to make the switch, as explained by Mr. Shantanu Kumar Singh, Executive Director of Taj Pharma Group.

The Transition to Film Coating with Auto Coater

1. The Shift Away from In-House Formulations

Before delving into the specifics of fully Automated film coatings, it’s important to understand the broader context. Many pharmaceutical companies were already considering a transition from complex, in-house tablet coating formulations to more streamlined, ready-made alternatives. The primary catalyst for this transition has been the growing concerns regarding the inherent risks associated with supply chains.

2. Taj Pharma Leading the Way

Taj Pharmaceuticals has emerged as a trailblazer in helping companies make the switch to fully Automated film coating systems. With manufacturing facilities strategically located across the globe, Taj Pharma ensures an uninterrupted supply of innovative solutions through its one-step Fully Automated Complete Film Coating System. This approach offers significant advantages when compared to the traditional DIY method.

3. One-Step Film Coatings: A Proven Solution

The concept of one-step film coatings for solid oral dose forms, pioneered by Taj Pharma, has been in existence for over half a century. It has become standard practice for most pharmaceutical manufacturing companies due to its efficiency and reliability.

4. The Benefits of Ready-Made Formulations

Compared to in-house coating, ready-made formulations provide a plethora of benefits, including reduced inventory management, improved coating efficiency, increased manufacturing capacity, batch-to-batch consistency, and cost reduction. Companies still clinging to in-house formulations have been slow to change, but the COVID-19 pandemic has shifted the paradigm. Minimizing risks in supply chains has taken precedence, and fully Automated coating systems are now being actively implemented.

The Complexities of In-House Coating

5. The Traditional Approach

Producing film coatings in-house involves numerous intricate steps. First, raw materials must be procured, followed by rigorous quality control procedures. These raw materials often come from multiple vendors, each requiring scrutiny and approval.

6. Inventory Management Challenges

Storing these raw materials adds another layer of complexity and cost. Pre-production and production stages introduce the risk of errors, given the multitude of ingredients involved.

7. Ensuring Homogeneity

Creating a homogenous suspension is no straightforward task, often necessitating high shear mixing. Dispensing coating materials introduces additional challenges, such as cleaning and the risk of cross-contamination.

8. Maintaining Consistent Color

Achieving consistent color is one of the most significant hurdles. Color consistency is reliant on the particle size distribution of pigments, and any variance can lead to variations in the final coating color.

The Simplicity of Fully Automated Coatings

9. Minimizing Risks with Fully Automated Coatings

On the flip side, fully Automated coatings are significantly less risky. They involve only one material from a single supplier and a single quality check. This approach streamlines documentation, simplifies handling, reduces production time, ensures consistent quality, and, crucially, minimizes supply chain risk.

10. The Role of a Reliable Coating Vendor

A reputable and reliable coating vendor conducts quality audits of its suppliers, maintains alternative sources of supply, and provides regulatory support. This ensures consistent quality and reliability.

11. Maintaining Color Consistency

Color uniformity is a challenging aspect, but Taj Pharma’s instrumental and visual color difference tests guarantee a consistent color every time. This meticulous testing process ensures that the color matches the specified standards.

The Lean Process Offered by Taj Pharma

12. Customized, One-Step Film Coating Systems

Taj Pharma offers customized, one-step film coating systems that combine essential ingredients—polymer, plasticizer, and pigment—in a dry concentrate. These formulations cater to a wide range of functional applications and color requirements.

13. Key Benefits

The benefits of these coatings go beyond productivity and cost savings. They include the elimination of separate inventories, simplified preparation, optimized equipment usage, quality control savings, batch-to-batch color consistency, a reliable supply chain for global pharmaceutical manufacturers, and expert technical and regulatory support.

14. The Role of Quality by Design (QbD) Principles

Taj Pharma employs four quality by design (QbD) principles to ensure the robustness of its Full Automated coatings. These principles include design of experiments (DoE), process validation, stability testing, and a unique master formulation.

15. Optimizing the Final Finish

While fully Automated coatings address many quality issues, the final finish is also influenced by critical process parameters (CPPs). These parameters include dispersion spray rate, spray distribution, process temperatures, airflow, coating solids concentration, pan loading, and pan speed.

Evaluating the Supplier Network

Evaluating the supplier network is a crucial step in ensuring the quality and reliability of coating materials. Service providers should adhere to good manufacturing practices, business continuity planning (BCP), and be continually monitored for performance. Taj Pharma has stringent guidelines in place to ensure finished product testing operates within a certified quality management system.

Superior Support by Taj Pharma

Taj Pharma goes the extra mile by providing superior support. With 22 technical support laboratories worldwide, customers can seek advice, run trials, and gain valuable insights on troubleshooting. The Taj Pharma Coating School offers an educational program that covers theoretical aspects of film coating, hands-on experience with laboratory and production-scale equipment, troubleshooting, and the latest developments in coating formulations.

In these challenging times, the pharmaceutical industry must adapt and innovate to maintain high-quality products and mitigate risks. The transition to lean, fully Automated film coatings represents a vital step in achieving these goals.

Frequently Asked Questions (FAQs)

1. Why are pharmaceutical companies moving away from in-house tablet coating?

Pharmaceutical companies are transitioning to fully Automated film coatings to reduce supply chain risks, increase efficiency, and improve product quality.

2. What benefits do fully Automated coatings offer?

Fully Automated coatings offer advantages such as reduced inventory management, improved coating efficiency, consistent color, and a reliable supply chain.

3. How does Taj Pharma ensure consistent color in its coatings?

Taj Pharma employs instrumental and visual color difference tests to guarantee a consistent color every time, ensuring it matches the specified standards.

4. What are the critical process parameters (CPPs) in the coating process?

Critical process parameters include dispersion spray rate, spray distribution, process temperatures, airflow, coating solids concentration, pan loading, and pan speed.

5. Why is it crucial to evaluate the supplier network?

Evaluating the supplier network ensures the quality and reliability of coating materials and helps minimize risk in the supply chain.