Solid oral dosage forms (SODFs) such as capsules, tablets, and sachets continue to play a pivotal role in the healthcare sector—they are patient-centric, easy to administer, and cost-effective solutions. The increasing demand for solid oral drugs raises pressure on pharmaceutical companies to manufacture quality drugs within the shortest possible time. However, the production of specific SODFs, particularly those having highly potent active pharmaceutical ingredients (APIs) from early development, requires a multidisciplinary approach and is efficient and modular. For many decades, the leading oral solid dosage manufacturing industries have used traditional batch production processes, which are complex and time-consuming. Certainly, the complex nature of drug molecules poses challenges in their scalability, formulation, bioavailability, and manufacturability.
At the same time, the trend of liquid biologics and precision medicines is coinciding with the development of oral solid dose formulation, creating challenges for drug manufacturers to focus on trends while setting the benchmark for OSDFs. To achieve the milestones, many oral solid dosage manufacturing marketleaders are navigating advanced technologies and emphasized contract services providers to overcome challenges and stay competitive in the market. Oral solid dosage contract manufacturing market is estimated to be USD 21 billion in 2023 and is anticipated to grow at a CAGR of ~5% during the forecast period, according to Roots Analysis. On the way to finding opportunities, let’s take a deep dive into the challenges faced by oral solid dosage manufacturing companies.
What is Oral Solid Dosage?
Oral solid dosage is a drug formulation that is consumed through the mouth in the form of capsules, tablets, and powders. The oral formulation is specifically designed to dissolve easily in the gastrointestinal tract, facilitating systemic delivery of the API into the body.
▪ Tablet is the most common oral solid dosage, which is generally developed by compressing a combination of excipients and active pharmaceutical ingredients.
▪ Chewable tablets are designed specifically for patients having difficulty swallowing capsules and tablets.
▪ Buccal and sublingual tablets are formulated to dissolve instantly into the mouth for the onset of action.
▪ Capsules are formulated with a gelatin shell having excipients and APIs inside it in the form of granules.
What Are the Advantages of Oral Solid Dosage?
Oral solid drug dosage is the easiest way to administer drugs for treatment. Other significances of oral solid dosage include:
⬝ Large scale production of oral solid dosage is economic and feasible in comparison to other forms.
⬝ Oral solid dosage has a long expiry date, it is easy to store for a long time.
⬝ Oral solid dosage is easy to pack, store and transport in bulk quantity.
⬝ Drug dosage accuracy is maintained because it is available in unit dosage form.
Common Challenges Face by Oral Solid Dosage Manufacturing Companies
The most common challenge lies in following the traditional oral solid dosage manufacturing process, which is defined as the dosing of the starter material within a set mass flow rate of mg/second (milligrams per second). The toxicity interlinked with highly potent APIs, deviation in the drug quality, complexity of oral solid dosage formulation, and transportation disruption are some other challenges that increase the gap between commercialization and formulation of the SODFs. Other common challenges faced by the oral solid dosage manufacturing market include the following:
1. Solubility of the Drug
Drug solubility refers to the ability of products to be dissolved into the liquid. The oral solid dosage is considered highly soluble when it requires a minimum solvent to dissolve completely. However, the low solubility of the drug leads to bad absorption and suboptimal drug efficiency and poses a risk of side effects. Drug solubility is generally affected due to the following reasons:
▪ Polarity: To achieve higher solubility, it is essential to ionize the formulation so the drug can easily absorb into the stomach or intestine. If the drug is not ionized completely, it may cause solubility problems.
▪ pH Level: The presence of hydrogen ions can affect the solubility of the oral solid dosage. If the oral solid drug has a low pH, it undergoes partial dissociation and may lead to low solubility in water.
▪ Size of Drug Particles: The particle size also affects the solubility of the oral solid dosage. If the particles are larger, they tend to have less solubility.
2. Bioavailability of the Oral Solid Dosage
Bioavailability refers to the amount of drug that is completely absorbed into the patient’s body or reaches systemic circulation. During oral solid dosage manufacturing, some parts may become inactive, and only a small amount of the drug reaches systemic circulation. The major concern arises during oral solid dosage manufacturing therapeutic effects from the drug already present in the bloodstream.
If the drug has low solubility, it cannot be dissolved into the bloodstream, which ultimately leads to poor bioavailability. Bioavailability is directly interlinked with solubility; therefore, both have to be addressed by oral solid dosage manufacturing companies first.
3. Technological Gap
Traditional oral solid dosage manufacturing companies face the pressure of adapting to technological advancements to mitigate the complex oral solid dosage product formulation problem. Oral solid dosage manufacturing companies need to possess more advanced contract development and manufacturing services that primarily emphasized delivering end-to-end solutions.
4. Continuous Discovery of Advance APIs
Since pharmaceutical companies are shifting to therapeutic discoveries and biological liquids, there is an increase in the development of new APIs for drug formulation that further enhance the requirement of an efficient approach to develop drugs with higher solubility rates. However, with the availability of the Food and Drug Association regulatory pathway, oral solid dosage manufacturing companies can leverage the predesigned safety and toxicity data to streamline and optimize their drug formulation. The solid pathway allows manufacturers easy evaluation of drug formulation techniques, excipients, API combinations, and dosage forms to provide better drug formulation options.
Technological Advancement is the Key to Address Challenges
In order to mitigate the above challenges while staying ahead of the competition, oral solid dosage manufacturing companies are focused on combined efforts to enhance drug formulation cost-effectively. Continuous manufacturing processes have been widely adopted to overcome solubility challenges. The system provides a controlled environment, increases API usage, and ensures minimal toxicity, ensuring high product quality.
In addition, the shift to continuous manufacturing helps to reduce operational costs and time, thereby bridging the gap between the manufacturing of oral solid dosage and market supply. The market leaders are also putting efforts into providing more responsive and agile manufacturing technologies, including 3D printing technology, nano-milling, and track and trace systems, enabling oral solid dosage companies to produce drug formulation efficiently.
Key Oral Solid Dosage Manufacturing Market Players
Some of the top oral solid dosage manufacturing market players are actively exploring advanced solutions to combat the challenges faced during the formulation of drugs.
- Aenova
- Alcami
- Almac
- Cambrex
- Catalent
- Hetero Drugs
- Lonza
- Rubicon Research
Oral Solid Dosage Manufacturing- A Paradigm Shift to the Future
The traditional transferring batch process from laboratory to large-scale production poses a challenge for oral solid dose manufacturing companies. Adoption of continuous processing successfully eliminates the challenges that hinder the development of quality drugs. With new R&D techniques and equipment, such as the automated design of experiments and test automation support functionality, manufacturers can meet the requirement of new oral solid dosage, maintain a continuous supply of solid dosage forms in the market, and meet future requirements.
About Roots Analysis
Roots Analysis is a global leader in the pharma/biotech market research. Having worked with over 750 clients worldwide, including Fortune 500 companies, start-ups, academia, venture capitalists, and strategic investors for more than a decade, we offer a highly analytical / data-driven perspective to a network of over 450,000 senior industry stakeholders looking for credible market insights. All reports provided by us are structured in a way that enables the reader to develop a thorough perspective on the given subject. Apart from writing reports on identified areas, we provide bespoke research/consulting services dedicated to serving our clients in the best possible way.
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