3D printing technology for customized pharmaceutical dosage forms

The invention utilizes 3D printing with selective laser sintering to create pharmaceutical tablets from amorphous solid dispersions, enhancing drug solubility and bioavailability without additional excipients, allowing customizable drug release rates and unique dosage forms.

Background

In the pharmaceutical industry, the development of drugs with poor aqueous solubility presents a significant challenge, as it often leads to low bioavailability. Many drugs fall into this category, particularly those classified under the biopharmaceutical classification system (BCS) classes II and IV.

To address this issue, amorphous solid dispersions (ASDs) have been adopted as a formulation technique to enhance the solubility and bioavailability of these drugs. ASDs stabilize the amorphous drug within a polymeric matrix, preventing recrystallization and ensuring controlled release. However, existing methods for preparing ASDs, such as hot-melt extrusion and spray drying, have limitations. These include the potential for recrystallization during processing and the need for additional post-processing steps to form final dosage forms.

Selective laser sintering (SLS) 3D printing has emerged as a promising method for producing pharmaceutical tablets, offering the ability to tailor drug release and create patient-specific medications. Yet, the energy required in SLS processes often leads to the crystallization of the active pharmaceutical ingredient, undermining the benefits of the amorphous state. Consequently, there is a need for innovative approaches that can effectively process ASDs into final dosage forms while retaining their amorphous nature and enhancing drug delivery.

Technology description

This technology utilizes 3D printing techniques, specifically selective laser sintering (SLS), to create pharmaceutical dosage forms from amorphous solid dispersions (ASDs). ASDs are crucial for enhancing the solubility and bioavailability of drugs that are poorly soluble. The method allows for the direct conversion of ASDs into tablet forms without the need for additional excipients, which are typically required in traditional methods. This approach can be applied to ASDs produced by various processes such as KinetiSol, hot-melt extrusion, and spray drying.

The technology also enables the customization of drug release rates, and the creation of unique dosage shapes tailored for specific applications, overcoming limitations like reduced drug release capabilities due to compression in current ASD processing methods.

The differentiation of this technology lies in its ability to streamline the production of pharmaceutical tablets by eliminating the need for excipients and additional processing steps. By using SLS, the method maintains the amorphous nature of the active pharmaceutical ingredient, which is essential for ensuring enhanced solubility and bioavailability.

This is a significant advancement over traditional methods that often lead to recrystallization, reducing the efficacy of the drug. Moreover, the ability to customize drug release profiles and dosage forms offers a tailored approach to drug delivery, potentially improving patient outcomes. The feasibility of this technique has been demonstrated, indicating its potential for broader application in pharmaceutical manufacturing, making it a promising innovation in drug formulation and delivery systems.

Benefits

Enhances solubility and bioavailability of poorly soluble drugs
Direct printing of ASDs into final dosage forms without additional excipients
Customization of drug release rates and unique dosage shapes
Overcomes limitations of current ASD processing methods, such as reduced drug release due to compression
Potential for broader application in pharmaceutical manufacturing
Single-step, post-processing technology applicable to various ASD manufacturing techniques
Reduces tablet size, increasing available drug dosages
Feasibility demonstrated with potential for use with other processes