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The Right Prescription for Oral Drug Manufacturing

Oral-Administered Drugs: Crucial, But Challenging

Convenient, cost-effective, and better for patient compliance, oral drug administration remains the preferred route. Common oral dosage forms include:
  • Solid forms: tablets, chewables, sublingual tablets, and powders
  • Semi-solid forms: soft gel capsules and liquid-filled hard shells (LFHS)
  • Liquids: solutions, suspensions, and emulsions
However, formulating oral drugs comes with challenges, including poor solubility, bioavailability, and lipophilicity.
  • Aqueous solubility: How well a drug dissolves in water. Poor solubility limits bioavailability, requiring higher doses to have therapeutic effects.
  • Bioavailability: The fraction of the drug that enters circulation and can have an active effect.
  • Lipophilicity: How well a drug dissolves in lipids. Greater lipophilicity typically improves distribution and binding but hurts solubility.
This is where formulation development comes in.

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Complex Oral Drugs Call for Advanced Expertise

Poor solubility and bioavailability threaten progress, but the right CDMO can overcome challenges—avoiding delays and delivering impact.
Many factors make drug products complex. Examples requiring precision handling and licensed facilities include:
  • Highly potent active pharmaceutical ingredients (HPAPIs) have occupational exposure limits (OELs) ≤ 10 μg/m3 air (8-hour time-weighted average) or can cause mutations, developmental defects, or reproductive toxicity at low doses.
  • DEA-controlled substances (Schedule I-V, L1) are strictly regulated based on medical use and abuse potential.
  • Hormones are chemical messengers regulating critical bodily functions like growth, mood, and reproduction.
  • Drugs with multiple APIs require advanced formulation strategies for stability, compatibility, and consistency.
Optimized delivery is critical for complex drugs to work as intended. Particle engineering boosts bioavailability, while excipients improve stability—ensuring effective, safe drug products.

Top-Form Solutions for Oral Drug Delivery

Oral-administered drugs come in a range of formats. Get familiar with key examples—no fluff, just the details you need.

Biopharmaceutics Classification System (BCS)

Categorizes drugs based on their permeability and solubility. Understanding these factors ensures optimal drug formulation and delivery.
  • Class I: high permeability, high solubility
  • Class II: high permeability, low solubility
  • Class III: low permeability, high solubility
  • Class IV: low permeability, low solubility

Soft Gel Capsules

Suitable for complex formulations, including hormones and products with multiple APIs, soft gels continue to rise in popularity. However, creating soft gel capsules that perform as intended is highly complicated.

Benefits include:

  • Suspension of water-insoluble substances
  • Enables higher drug concentrations
  • Reduced need for cosolvents
  • Easy-to-swallow, taste-masked formats
  • Flexible dosage sizes, shapes, and colors

Liquid Filled Hard Shells (LFHS)

Non-aqueous liquids within hard gelatin capsules, LFHS offer a versatile solution for solubility challenges and boosting bioavailability.

Benefits include:

  • Suspension of water-insoluble substances
  • Enables higher drug concentrations
  • Reduced need for cosolvents
  • Easy-to-swallow, taste-masked formats
  • Flexible dosage sizes, shapes, and colors

Tablets

Versatile oral dosage forms that come in many shapes and sizes, made by compressing active ingredients with excipients.
  • Coated Tablets control drug release, mask taste, or make swallowing easier. The coating may also protect the tablet from moisture and bacteria.
  • Orally Disintegrating Tablets (ODTs) and Sublingual Tablets are patient-friendly, especially for pediatric use. ODTs disintegrate in the mouth, while sublingual tablets dissolve under the tongue. Both require taste masking.

Capsules

Medication enclosed in an outer shell that dissolves in the digestive tract, allowing the drug to be absorbed into the bloodstream.

Chewables

Designed to be chewed before swallowing, these tablets must be palatable and easy to consume.

Powders

Mixtures of active drugs and excipients, powders are often packaged in stick-packs or specialized papers for easy use.

Liquids

Including solutions, suspensions, emulsions, and syrups, liquid oral dosage forms are ideal for patients with difficulty swallowing solids, offering flexible dosing and rapid absorption. However, they often have shorter shelf lives compared to solid oral drug products.

Adaptability Matters in Oral CTM

Oral clinical trial manufacturing (CTM) ensures consistent, high-quality batches for clinical studies, including oral drug repurposing trials.
With shifting timelines, evolving formulations, and GMP requirements, flexible manufacturing keeps you on track.
How We Tackle Complex CTM

Delivering Reliability and Stability at Scale

Scaling up oral drug manufacturing demands precision and foresight.
Combining agile operations with robust processes and quality controls ensures seamless transitions from development through commercial—without delays.
Get Solutions at Scale

No Compromises on Quality

The stakes are too high for anything less than top-notch oral drug manufacturing. Adherence to FDA-defined cGMP regulations is critical, whether in-house or through a CDMO partner.
cGMP standards ensure that drug products meet strict identity, strength, quality, and purity criteria. These guidelines regulate the design, monitoring, and control of pharmaceutical manufacturing processes and facilities to ensure drug products deliver exactly what they promise—no ifs or buts.
Our Quality Assurance

The Right CDMO Partner Makes All the Difference

Let’s Talk Oral Manufacturing
For many small or virtual pharmaceutical companies, partnering with an experienced CDMO eliminates stress—no need to invest in expensive equipment or navigate the regulatory maze alone.

The process starts with tech transfer. Look for a CDMO that brings:

  • Deep product understanding
  • Oral manufacturing expertise
  • Robust control strategies
  • Rock-solid process validation
  • An unwavering commitment to quality and compliance
Technical experts provide specialized knowledge to deliver manufacturing excellence. Our dedicated team of gritty problem solvers draws on decades of hands-on experience to ensure precision and quality, no matter how complex your project.
Skilled project managers keep teams aligned. They ensure transparent communication and smooth collaboration, anticipate challenges, and adapt to evolving needs to deliver on time, in full—every time.
With the right CDMO, oral drug manufacturing becomes seamless—no headaches, just precision and progress.
Let’s Talk Oral Manufacturing
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