Y. Takeuchi

• Gifu Pharmaceutical University

Background/Objectives: Orally disintegrating film (ODF) is prepared using water-soluble polymers as film-forming agents. To improve mechanical and disintegration properties, some polymers need to be blended with others. This study aimed to investigate the utility of hydroxypropyl cellulose (HPC) and hydroxypropyl methyl cellulose (HPMC) as blend fi...

Orally disintegrating films (ODFs) are one of the most important pharmaceutical oral dosage forms. However, it has been noted that the hygroscopicity of ODFs damages their stability and mechanical strength. We prepared model ODFs with three different water contents by storage under different relative humidity conditions in order to examine the effe...

Characteristics of residence time distribution (RTD) in a continuous high shear mixer granulation were investigated to promote the development of a continuous manufacturing process in the pharmaceutical industry. A continuous granulator with an impeller and a scraper was utilized. The tracer behavior in the continuous wet granulation was verified i...

The tensile test is the most widely used method for testing the mechanical characteristics of orally disintegrating films (ODFs). The other available test is the folding endurance (FE) test, which is more suitable for clarifying the actual strength during the manufacturing and dosing. However, the FE test is performed manually, and the FE number it...

In the present study, surface-modified punches with different roughness were evaluated for their ability to prevent sticking during pharmaceutical tableting using a single punch machine. The surface roughness of the punch faces was assessed using a laser microscope. Acetaminophen and ibuprofen were used as model active pharmaceutical ingredients (A...

The control of residence time in a powder mixing process was investigated toward the development of a continuous pharmaceutical manufacturing system. A powder mixer equipped with an impeller and a scraper, which was designed for a continuous granulation machine, was used. The mixing homogeneity and dynamic behavior of the powder in the mixer were i...

The most important issue in the design of orally disintegrating films (ODFs) is the control of the ODFs' disintegration properties. A better understanding of the mechanisms of ingredients used to promote or disturb the disintegration time of ODFs would improve the development of ODF formulations. Here we focused on the advantage of adding insoluble...

In the design of the orally disintegrating films (ODFs), it is important to determine the disintegration time (DT) precisely and properly. These films’ DTs are usually assessed by a disintegration test defined in the pharmacopoeias, but under the conditions of such tests, a much larger volume of water is used and a stronger up-down movement is appl...

Hydroxypropyl cellulose (HPC) is a water-soluble polymer used as a binder during pharmaceutical tableting and granulation. HPC is also known as a base material for pharmaceutical film by virtue of its film formability with excellent plasticity. The aim of this study was to assess the applicability of HPC to orally disintegrating film (ODF) and to i...

In the manufacture of tablets, especially in direct tableting processes, the flowability of excipient powders and formulated powders is one of the most important characteristics. In the past two decades, orally disintegrating tablets (ODTs) have been prepared as popular solid dosage forms for elderly patients. Many types of mannitol granules have b...

Taste detection systems using electronic sensors are needed in the field of pharmaceutical design. The aim of this study was to propose an advanced technique using a taste-sensing system to evaluate the bitterness of an orally disintegrating film (ODF) samples. In this system, a solid film sample is kept in the test medium with stirring, and the se...

We previously determined “Tableting properties” by using a multi-functional single-punch tablet press (GTP-1). We plotted “Compactability” on the x-axis against “Manufacturability” on the y-axis to allow visual evaluation of “Tableting properties”. Here, we examined whether this evaluation method can be used in the formulation design of tablets pre...

We previously determined “Tableting properties” by using a multi-functional single-punch tablet press (GTP-1). We proposed plotting “Compactability” on the x-axis against “Manufacturability” on the y-axis to allow visual evaluation of “Tableting properties”. Various types of tableting failure occur in commercial drug production and are influenced b...

In the early development stage of orally disintegrating films (ODFs), suitable evaluation methods must be used. The aim of this study was to demonstrate the feasibility of using an electronic taste sensor and a flow-through cell for ODFs. A pullulan film loaded with donepezil hydrochloride (DH) was designed, as a model ODF. The film was prepared us...

Before designing tablet formulations, it is important to understand the “Tableting Properties” of excipients and API (active pharmaceutical ingredient) powders. Those properties refer to “Compressibility”, “Compactability” and “Manufacturability”, which are difficult to evaluate quantitatively. In this study, we aimed to evaluate the “Tableting Pro...

The purpose of this study was to prepare a co-ground mixture of erythritol and micronized crospovidone (M-CPVP) to prepare the orally disintegrating tablets (ODTs) by directly compressing. The co-ground mixture was prepared by ball milling. Several processing time for ball mill and the different ratio of M-CPVP / erythritol were tested to determine...

The purpose of this study was to develop pharmaceutical thin films that disintegrate rapidly in the oral cavity. Films containing acetaminophen as a model drug were prepared by the solution/solvent casting method. HPMC as a polymeric film former, MCC and pregelatinized starch as disintegrants, and micronized L-HPC as both a film former and a disint...

The purpose of this study was to prepare orally disintegrating tablets (ODTs) by directly compressing a mixture of sugar alcohol (mannitol) and micronized crospovidone (M-CPVP). When the mixture of mannitol and M-CPVP was co-processed by ball milling, the physicochemical properties of the resultant tablets were considerably improved, particularly t...

Lactobacilli (streptococcus faecalis WB2000) are effective in controlling plaque, in preventing dental caries and periodontal disease and in preventing halitosis. In this study, pharmaceutical thin films, with live lactobacilli, were developed and examined as a dosage form that disintegrates rapidly and stays in the oral cavity. Four dosage forms w...