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Solid State Testing of Inhaled Formulations
Published in Anthony J. Hickey, Sandro R.P. da Rocha, Pharmaceutical Inhalation Aerosol Technology, 2019
Philip Chi Lip Kwok, Hak-Kim Chan
The measurement procedure is simple and is specified in the pharmacopoeias (British Pharmacopoeia 2017, European Pharmacopoeia 2017, United States Pharmacopeia 40-National Formulary 35 2017). Essentially, a powder is poured freely into a 250 mL graduated measuring cylinder so that the untapped filling volume is 150 mL–250 mL. The mass of, and volume occupied by, the powder in the cylinder are then used to calculate the bulk density. The cylinder is then tapped for 10 taps, 500 taps, and 1250 taps by a tapping apparatus (British Pharmacopoeia 2017, European Pharmacopoeia 2017, United States Pharmacopeia 40-National Formulary 35 2017). The volumes occupied by the powder after each tapping episode are recorded. If the difference in the volumes after 500 taps and after 1250 is ≤2 mL, then the volume after 1250 taps is the tapped volume. Otherwise, repeat the tapping in increments of 1250 taps until the difference between two consecutive tapping episodes is ≤2 mL. The tapped volume is then used to calculate the tapped density.
Dry-Fill Formulation and Filling Technology
Published in Larry L. Augsburger, Stephen W. Hoag, Pharmaceutical Dosage Forms, 2017
Pavan Heda, Vikas Agarwal, Shailesh K. Singh
Good flow is necessary to produce a working powder bed that can reform adequately after doses have been removed. A degree of compactibility or cohesiveness under pressure is important to prevent loss of material from the end of the plug during transport to the capsule shell. Sufficient lubricity in a formulation is needed to permit easy and efficient ejection of the plug and prevent or minimize adhesion to the tooling and other surfaces in contact with the formulation. The necessity for a reasonable bulk density becomes important when dealing with active ingredients that are administered in large doses, since the formulation is limited by the available or preferred capsule sizes.
Granulation Characterization
Published in Dilip M. Parikh, Handbook of Pharmaceutical Granulation Technology, 2021
A particle, as defined by United States Pharmacopeia (USP) < 776 > , is the smallest discrete unit of mass [1]. Thus, a particle does not need to be a stand-alone individual but must be discretely recognized. A primary particle is that same small discrete unit of mass bound into a granule or agglomerate. A granule is made up of primary particles that are firmly bonded together (will survive sieve testing). Bond former present in the transitional space is the “glue” holding the primary particles together. The transition’s composition is normally a disordered region, a semisolid and/or polymer boundary layer, that can extend to or be the surface of the granule. A “moving units” in a compressive process is a particle or particle fragment that is surviving the compression event [2]. “Moving units” as particles move through voidage during compression and remain intact. “Moving units” thus can be granules at low pressure, primary particles or fractured particles at higher pressures. Moving units can also be semisolids following under pressure. Voids in a granulation bed represent the volume or the space between particles in a granulation bed. As applied to granulation, the voids will be considered bed porosity. Bulk density as tested by USP <616> [3] is the mass of the granulation divided by the volume occupied, which includes voidage space between the particles and the porosity in the particles. Skeletal density considers the mass in the volume occupied by solid material including the volume in any closed pores within the granules (ASTM D3766). True density is mass in the volume that also excludes closed pores, thus it can be denser than skeletal density.
Mini-tablets as technological strategy for modified release of morphine sulfate
Published in Pharmaceutical Development and Technology, 2022
Raizza Tafet Carminato e Silva, Marcos Luciano Bruschi
The flowability of the particle is essential to ensure successful production of tablets, being considered a critical factor (Crowder and Hickey 2000; Qiu and Zhang 2000). The flow of powders is influenced by many factors such as size, shape and particle size distribution, surface texture and energy, composition chemistry, moisture content, and others (Prescott and Barnum 2000). Bulk density is a characteristic of the powder as a whole and depends on how the particles themselves are arranged and the porosity coming from the powder bed (Aulton 2001). Formulation F3 displayed value of bulk density greater than formulations F1 and F2 (p < 0.05), which was influenced by the greater amount of lactose present in this formulation (Table 2). Lactose is a diluent that can form strong inter-particle bonds leading to the formation of very cohesive and high-density tablets (Cal et al. 1996).
Thermal, structural, antimicrobial, and physicochemical characterisation of thyme essential oil encapsulated in β- and γ-cyclodextrin
Published in Journal of Microencapsulation, 2022
Jasim Ahmed, Mehrajfatema Z. Mulla, Hassan Al-Attar, Shaikhah AlZuwayed, Mohammed Ejaz, Sarah Al-Jassar, Harsha Jacob, Linu Thomas, Noor Al-Ruwaih, Antony Joseph
Bulk density (ρb) is one of the important parameters used for handling, formulating, and packaging dried materials. The ρb of the BCD was significantly higher (700 kg·m−3) than that of the GCD (480 kg·m−3) indicating the BCD requires less space for packaging than the GCD (Table 2). The freeze-drying process produced porous structures that resulted in a significant drop in the ρb. The BCD/TEO powder with a ratio of 85/15 had a lower bulk density (240 kg·m−3) than the GCD/TEO (290 kg·m−3) at a similar ratio. GCD/TEO at 80/20 (w/w), on the other hand, had a higher bulk density (320 kg·m−3) than BCD/TEO (270 kg·m−3) (Baysan et al. 2021). The reported bulk density values for encapsulated spray dried and freeze-dried propolis powders ranged from 240 to 340 and 200 to 340 kg·m−3, respectively, which supports the bulk density of the present work.
Enhanced dissolution of sildenafil citrate as dry foam tablets
Published in Pharmaceutical Development and Technology, 2019
Somchai Sawatdee, Apichart Atipairin, Attawadee Sae Yoon, Teerapol Srichana, Narumon Changsan
An accurately weighed amount of powder was passed through a #40 sieve and carefully poured into a graduated cylinder. The powder bed in the cylinder was then made uniform without disturbance. The volume was measured directly from the graduation marks on the cylinder in mL. The measured volume was called the bulk volume, and the bulk density was calculated by bulk volume divided by the powder weight. The same measuring cylinder was set into the tap density apparatus (PT-TD200, Pharma Test, Germany). The tap density apparatus was set to 300 taps/min and operated for 500 taps. The volume was noted as Va and again tapped for 750 times and the volume was noted as Vb. If the difference between Va and Vb was not greater than 2%, and then, Vb was considered to be the final tapped volume. The tapped density was calculated by dividing the powder weight (Sivakranth et al. 2011; United States Pharmacopeial Convention 2012). The Carr compressibility index was calculated from the bulk and tapped density according to the following formula that was described in USP36 < 616 > (United States Pharmacopeial Convention 2012).