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9 Bioprinting in Pharmaceuticals 321

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Regulatory Perspective of Additive

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Manufacturing in the Field of Pharmaceuticals

Ziyaur Rahman, Naseem A. Charoo, Eman M. Mohamed, Mathew Kuttolamadom, and Mansoor A. Khan

Abstract

Spritam ® is the ﬁrst 3D printed drug product approved by the FDA for clinical use. 3D printed drug product has to meet the standards of identity, strength, quality, and purity. Generally, the regulatory pathway to be followed in obtaining marketing authorization does not change with a manufacturing method employed in preparing a drug product or a device. New drug application can be submitted via 505(b)(1) or 505(b)(2) regulatory pathway, while abbreviated new drug application (generics) through 505j regulatory pathway. Generic versions of a branded product can be prepared by using a different manufacturing process than the one used by the branded product. For example, the generic version

of Spritam method. As per the regulation, the sponsor of generic product has to demonstrate

pharmaceutical equivalence and bioequivalence with Spritam the adoption of novel technology in drug product manufacturing, including 3D

does not need to be manufactured by any additive manufacturing

. To encourage

Z. Rahman () · M. A. Khan Irma Lerma Rangel College of Pharmacy, Texas A&M Health Science Center, Texas A&M University, College Station, TX, USA e-mail:

rahman_76@tamu.edu

N. A. Charoo Succor Pharma Solutions, 216-Laboratory Complex, Dubai Science Park, Dubai, UAE

Centric Compounding LLC, 216-Laboratory Complex, Dubai Science Park, Dubai, UAE

E. M. Mohamed Irma Lerma Rangel College of Pharmacy, Texas A&M Health Science Center, Texas A&M University, College Station, TX, USA

Department of Pharmaceutics, Faculty of Pharmacy, Beni-Suef University, Beni-Suef, Egypt

M. Kuttolamadom College of Engineering, Texas A&M University, College Station, TX, USA

https://doi.org/10.1007/978-981-99-2404- 2_10

327

328 Z. Rahman et al.

printing, the FDA/CDER has established “Emerging Technology Program” to guide sponsors in identifying and resolving potential technical and regulatory challenges. This chapter reviews primarily the regulatory aspects of 3D printed drug products.

Keywords

3D printing; Excipients; Process; PAT; Recycling; Stability; Quality defects; Regulatory aspects

10.1 Introduction

Additive manufacturing (AM) technology is a broad term encompassing technologies that create objects by adding material either layer by layer (layering process) or by using some other methods. 3D printing (3DP) which is known as rapid prototyping or additive manufacturing is in fact a type of AM technology which involves the creation of objects by a layering process (Jamróz et al. International Organization for Standardization deﬁnes 3DP as “The fabrication of objects through the deposition of a material using a print head, nozzle or other printing technology” (ISO/ASTM52900

2021). The potential application of 3DP

in printing drug products, medical devices, and biologics is widely reported in the literature (Lerman et al.

2018, Beg et al. 2020, Willson and Atala 2022). The FDA

has approved a number of medical devices and a drug product manufactured by 3DP. The primary motivation behind using 3DP in medical products is personalization of treatment that includes drug products, devices, or combining both in a single system (Rahman et al.

2018). For drug products, it provides the ability to tailor

the dose, shape, size, and release characteristics based on patients’ needs. Certain 3DP processes may require fewer processing steps or excipients as compared to traditional pharmaceutical manufacturing methods. Moreover, drug products or devices can be produced in hospitals, clinics, pharmacies, or remote locations, thus enabling on-demand production of drug products/devices at places that lack cold storage facilities, battleﬁelds, or space (Charoo et al.

2020). For pharmaceutical

companies, it signiﬁcantly reduces cost, waste, and time spent in developing a product and later scaling it up since 3DP is usually a scale-independent process (Zhu et al.

2020). Despite these advantages over traditional manufacturing processes and

potential applications, there are regulatory and technical challenges that preclude widespread adoption of these technologies, especially in pharmaceutical manufacturing. Some of the challenges requiring further investigation include process monitoring, material attributes, quality attributes, material recycling, etc. (Rahman et al.

2018, Charoo et al. 2020).

2018). The

10 Regulatory Perspective of Additive Manufacturing in the Field . . . 329

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10.2 Overview of 3D Printing Technologies

3DP is a collection of technologies to deposit raw material as layers. Fundamentally, they differ in raw material physical form and technologies to fuse the layers. In general, physical form of the raw material required for printing is dictated by the 3DP process. Fusion of layers is accomplished by liquid binder, UV/laser light, heat, or a combination of two or more methods. After printing an object, postprocessing may be required to impart additional mechanical strength or speciﬁc features (Rahman et al.

2018). The following 3DP techniques are used in printing

medical devices and drug delivery systems:

1. Stereolithography

2. Fused deposition modeling

3. Melt-extrusion deposition

4. Semisolid extrusion

5. Drop on powder/binder jetting

6. Selective laser sintering

10.2.1 Stereolithography (SLA)

It was ﬁrst reported by Hideo Kodama, a Japanese researcher. Later on, Charles W. Hull coined the term “stereolithography” and patented the technology in 1984. He also established 3D systems and launched the ﬁrst SLA printer in 1987 (Perez-Arjona et al. monomer/oligomer that polymerizes in the presence of UV light. Generally, the monomers/oligomers are multifunctional methacrylates or acrylic esters. The building platform is submerged in a vat of liquid oligomer, and UV light scans the deﬁned area over the platform to convert liquid resin into a solid state followed by Z-axis downward movement. Subsequently, UV scanning of a new layer of liquid oligomer is performed over the already formed solid layer (Fig. This process is repeated till a desired structure is formed (Deshmane et al. However, challenges of SLS process include drug solubility, safety of oligomers, unreacted monomers/oligomers, drug-oligomer interactions, etc. Solubility of drugs in oligomers is essential to prevent drug settling during the printing process. Poorly soluble drug molecules and/or precipitation during the printing process can lead to nonuniform drug distribution in the printed dosage forms. Preferably, the drug should be in the colloidal size range, and the oligomer-drug mixture should be continuously stirred during printing process to prevent drug settling. To the best of our knowledge, none of the oligomers/monomers reported for pharmaceutical applications have been approved by the FDA. Moreover, there are limited options with regard to selecting monomers/polymers. It should be from generally regarded as safe (GRAS) or inactive ingredient (IIG) database. Most commonly used monomers are based on methacrylates that have a polymerization rate of 60–90%. The unreacted oligomers may cause allergic reactions and cytotoxicity upon direct

2003, Rahman et al. 2018). This technology uses liquid

10.1a).

2021).

330 Z. Rahman et al.

Fig. 10.1 (a) Stereolithography, (b) ﬁlament deposition modeling, (c) melt-extrusion deposition, (d) semisolid extrusion, (e) binder jetting and selective laser sintering 3D printing technologies

contact with human cells. Furthermore, degradation products of methacrylate can cause local decrease in pH that could affect surrounding tissues (Oesterreicher et al.

2016, Oskui et al. 2016, Alifui-Segbaya et al. 2018,Xuetal. 2021). A drug may

react with a liquid oligomer that may compromise safety and efﬁcacy of the printed dosage form. For instance, Michael addition reaction is reported between amino group of amlodipine and diacrylate group of poly(ethylene glycol) diacrylate (Xu et al.

2020).

10.2.2 Fused Deposition Modeling (FDM)

This method is most widely reported in the literature for pharmaceutical applications. It is also known as fused ﬁlament fabrication and was invented by S. Scott Crump in 1980, who later patented the technology in 1989 (Crump SLA method, this technique does not require post-processing of the printed delivery system. However, the resolution of FDM printed dosage form is poor compared to the SLA method. Furthermore, it needs a thermoplastic polymer in a ﬁlament form, necessitating the stability of formulation components. Filament is extruded through the nozzle of a print head to soften and melt it. The melted ﬁlament is

1992). Unlike the

10 Regulatory Perspective of Additive Manufacturing in the Field . . . 331

Данная книга находится в списке для перевода на русский язык сайта https://meduniver.com/

extruded over the building platform in a speciﬁc manner to build a 3D object. The next layer is extruded over the already printed layer followed by layer fusion (Fig.

10.1b). Drug is loaded into the ﬁlament by soaking it into a drug solution before

printing. The soaking method suffers from many disadvantages including low drug loading, high drug loss, change in dimension of ﬁlament, and long processing time. Hot-melt extrusion (HME) process is frequently utilized to prepare drug-loaded ﬁlament as it allows processing of formulation components in powder form and addition of other excipients with short processing time and high drug loading. However, it increases thermal exposure during this process that represents a risk to the formulation components. To reduce processing time and thermal exposure time, FDM can be coupled with the HME in a single process (Dumpa et al.

2021).

Some of the challenges of FDM process are drug phase transformation, stability, impurity, etc. (Parulski et al.

2021).

10.2.3 Melt-extrusion Deposition (MED)

This technology is relatively new and was reported in 2021. The basic principle is similar to FDM except that it does not require formulation in ﬁlament form (Fig.

10.1c). In this technique, powder formulation is converted into softened or molten

mass followed by layer-by-layer deposition to produce dosage forms (Zheng et al.

2021).

10.2.4 Semisolid Extrusion (SSE)

It is based on extrusion principle. In SSE, formulation components in gel or paste form are extruded through a syringe under a pneumatic, mechanical, or solenoidbased system (Seoane-Viaño et al. remove the solvent and impart necessary mechanical strength to the printed dosage forms. This printing method allows the printing of thermally labile drugs as it does not require a thermoplastic polymer (Fig. agent is required to hold the formulation components and maintain the shape during printing and after drying. This method is not suitable to drugs susceptible to aqueous or solvent hydrolysis (Rahman and Quodbach

Drop on powder/binder jetting (BJ): Binder jetting was developed by Ely

Sachs and Michael Cima at the Massachusetts Institute of Technology in 1993. It was later commercialized by Z Corp. The ﬁrst 3D printed drug product (Spritam is based on BJ process. Aprecia (manufacturer of Spritam

technology. In this technology, powder formulation is spread as a layer over the building platform followed by spraying of binder or solvent over the selected region of the powder bed. Building platform moves down in the Z-axis by a thickness of the layer followed by repetition of powder layering and binder jetting till the desired dosage form is obtained. The spraying of the solvent/binder solution provides the necessary adhesive force required to bind formulation components

2021). A post-processing step is required to

10.1d). Nonetheless, a gelling or binding

2021).

) calls it ZipDose

)

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