THREE-DIMENSIONAL PRINTING TECHNOLOGY IN TABLET DOSAGE FORM DESIGN AND DEVELOPMENT

Yıl 2024, Cilt: 48 Sayı: 1, 384 - 395, 20.01.2024

Sevgi Tektaş Şeyda Güneş Prof. Dr. Nilüfer Yuksel

https://doi.org/10.33483/jfpau.1353676

Öz

Objective: Three-dimensional (3D) printing, also known as additive manufacturing, has revolutionized various industrial fields such as engineering, architecture and space sciences. As a promising technology in the field of pharmacy in recent years, 3D printing appears as an advantageous approach to produce personalized solid dosage forms, implants and medical devices with high precision and accuracy. This technology has the potential to overcome some of the limitations of traditional pharmaceutical manufacturing processes and offers benefits such as improved dosage form design, increased patient compliance, and reduced manufacturing costs. Within the scope of this review, tablet production methods with 3D printing were examined.
Result and Discussion: Among the different routes for administering dosage forms, the oral route is the most preferred route of administration regarding patient compliance. The production, processing and storage of tablets for oral administration is easier and more economical than other dosage forms. 3D printing enables the formulation and production of tablets with different geometric shapes and different active ingredient release profiles. Although this printing technology basically consists of the same printing stages, it is quite diversified within itself and is divided into seven different methods by the American Society for Testing and Materials. Among these various methods, the melt deposition modeling method, which is very successful in tablet production, has been the subject of many studies. However, tablets and caplets can be produced with all 3D printing methods. However, there is no established framework to demonstrate quality and safety for personalized medicines, and 3D technology may have risks such as counterfeit medicine, proliferation of illegal drugs and mislabeling. For 3D production, it is necessary to adopt good manufacturing practices (GMP), establish standard operating procedures, and conduct quality control (e.g. content uniformity, mass uniformity, dissolution testing in tablets) throughout the entire production line and subsequently on the finished product.

Anahtar Kelimeler

3D printing, inkjet, photopolimerization, powder bed fusion, printing methods

TABLET DOZAJ FORMLARININ TASARIMINDA VE GELİŞTİRİLMESİNDE ÜÇ-BOYUTLU BASKI TEKNOLOJİSİ

Öz

Amaç: Eklemeli üretim olarak da bilinen üç boyutlu (3B) baskı, mühendislik, mimarlık ve uzay bilimleri gibi çeşitli endüstriyel alanlarda devrim yaratmıştır. Son yıllarda eczacılık alanında da umut vadeden bir teknoloji olarak 3B baskı, kişiselleştirilmiş katı dozaj formları, implantlar ve tıbbi cihazları yüksek hassasiyet ve doğrulukla üretmek için avantajlı bir yaklaşım olarak karşımıza çıkmaktadır. Bu teknoloji, geleneksel farmasötik üretim proseslerinin bazı sınırlamalarının üstesinden gelme potansiyeline sahiptir ve gelişmiş dozaj formu tasarımı, artan hasta uyuncu ve azaltılmış üretim maliyetleri gibi avantajlar sunmaktadır. Bu derleme kapsamında 3B baskılama ile tablet üretim yöntemleri incelenmiştir.
Sonuç ve Tartışma: Dozaj formlarının uygulanmasına yönelik farklı yollar arasında oral yol, hasta uyuncu açısından en çok tercih edilen veriliş yoludur. Oral yolla veriliş için tabletlerin üretimi, işlenmesi ve depolanması diğer dozaj formlarına göre daha kolay ve ekonomiktir. 3B baskı, farklı geometrik şekillerde ve farklı etkin madde salım profillerine sahip tabletlerin formülasyonu ve üretimine imkân sağlamaktadır. Bu baskılama teknolojisi temel olarak aynı baskı aşamalardan oluşsa da kendi içinde oldukça çeşitlenmiş ve Amerikan Test ve Malzemeler Derneği tarafından yedi farklı yönteme ayrılmıştır. Bu çeşitli yöntemler arasında tablet üretiminde oldukça başarı sağlayan eriyik birikim modelleme yöntemi pek çok çalışmaya konu olmuştur. Bununla birlikte tüm 3B baskılama yöntemleri ile tabletler ve kapletler üretilebilmektedir. Ancak kişiselleştirilmiş ilaçlar için kalite ve emniyeti gösterecek belirlenmiş bir çerçeve bulunmamaktadır ve de 3B teknolojinin sahte ilaç, yasal olmayan ilaçların yaygınlaşması ve yanlış etiketleme gibi riskleri de olabilecektir. 3B üretim için iyi imalat uygulamalarının (GMP) benimsenmesi, standart işlem prosedürlerinin oluşturulması, tüm üretim hattında ve sonrasında bitmiş üründe kalite kontrolün (örneğin tabletlerde içerik tektürlülüğü, kütle tektürlülüğü, çözünme testi) yürütülmesi gereklidir.

Anahtar Kelimeler

3B baskı, baskılama yöntemleri, fotopolimerizasyon, mürekkep püskürtme, toz yatağı füzyon

Kaynakça

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