Lubrication properties of potential alternative lubricants, glycerin fatty acid esters, to magnesium stearate

Determination of Useful Ranges of Mixing Conditions for Glycerin Fatty Acid Ester by Multiple Regression Analysis

“…In our previous study, it was demonstrated that the lubrication performance of TR-FB and TR-HB at the same concentration was better immediately after the start of compression than that of Mg-St. 15) In addition, decreased tablet tensile strength (TS), prolonged disintegration time (DT), or retarded drug dissolution was not observed for TR-FB and TR-HB at a mixing time of 5 min, even when the lubricant concentration was increased to 3.0%. In contrast, these properties were deteriorated for Mg-St. 15,16) Therefore, the use of TR-FB or TR-HB as a lubricant produced tablets with uniform quality and without the pharmaceutical problems associated with Mg-St. However, only limited mixing conditions of TR-FB and TR-HB were examined similar to previous lubrication studies.…”

“…Recently, we have reported two types of glycerin fatty acid ester lubricants, triglycerin full behenate (TR-FB) and triglycerin half behenate (TR-HB), as potential alternatives to Mg-St. [14][15][16] Generally, Mg-St is used at a concentration of 0.5% during the manufacturing process, but it is necessary to discard initial tablets after starting compression until the uniform lubrication effect takes place. In our previous study, it was demonstrated that the lubrication performance of TR-FB and TR-HB at the same concentration was better immediately after the start of compression than that of Mg-St. 15) In addition, decreased tablet tensile strength (TS), prolonged disintegration time (DT), or retarded drug dissolution was not observed for TR-FB and TR-HB at a mixing time of 5 min, even when the lubricant concentration was increased to 3.0%.…”

“…A multiple linear regression analysis was conducted to verify the relationship between the mixing conditions and the lubrication properties, such as the pressure transmission ratio (PTR) and ejection force (EF), and the tablet properties, such as TS and DT. The useful range of mixing conditions that satisfied both the lubrication and tablet properties was also determined in order to quantitatively evaluate the potential of TR-FB as an alternative to Mg-St. 14,15) Lactose monohydrate (DFE Pharma Co., Ltd., Tokyo, Japan) and corn starch (Nihon Shokuhin Kakou Co., Ltd., Tokyo, Japan) were used as fillers, and solid-state hydroxypropylcellulose (HPC-L ® , Nippon Soda Co., Ltd., Tokyo, Japan) was used as a binder. All other excipients used in this study are listed in JP16.…”

“…Furthermore, PTR and EF were unchanged for mixing times between 30 and 60 min. 15) Therefore, lubricant concentrations of 0.07-3.0% and mixing times of 1-30 min were used in the present study. The normalized factor levels of the independent variables and the conditions for each batch are listed in Table 1.…”

Effect of the External Lubrication Method for a Rotary Tablet Press on the Adhesion of the Film Coating Layer

“…[4][5][6] In the external lubrication method, a lubricant is directly sprayed onto the punches and dies of a tableting machine using a lubricant spray nozzle before the powder is compressed during the compression process, and the lubricant is localized on the surface of the punches and dies.…”