Mannitol Spray-dried

Fig. 11 Sugar alcohols. Mannitol, crystalline (A), mannitol, spray dried (B), and sorbitol-instant, spray dried (C).

Fig. 14.15 Intra-particular cumulative volume upper curves) and pore size density distribution lower curves) of mannitol spray dried at different outlet temperatures (M67 Tom = 67 °C M84 = 84 °C M102 Tom = 102 °C) [32]...

In the human market, oral and parenteral dosage forms are prepared from the crystal. However, because of the extremely high potency, more dilute (0.1—10%) forms are avabable. These include dilutions with mannitol, triturations on dicalcium phosphate or resins, and spray-dried forms. Prices for these forms are driven by that of the crystal, which in early 1996 was ca 9.50/gram (95). Prices for the vitamin have risen during the first half of the 1990s. However, Htde growth in price beyond inflation is anticipated. 

N. Dasovich, T.D. Sweeney, S.J. Shire, C.C. Hsn, and Y.E Maa, Effect of mannitol crystallization on the stability and aerosol performance of a spray-dried pharmaceutical protein, recombinant humanized anti-IgE monoclonal antibody. J Pharm Sci, 1998. 87(11) 1406-11. 

There are many commercially available direct compression filler-binders. The most commonly used filler-binders include spray-dried lactose, mannitol, microcrystalline cellulose, pregelatinized starch, and dibasic calcium phosphate. Many factors affect the selection of a filler-binder for a direct compression tablet formulation. The most important requirements for a directly compressible filler-binder used in a low-dose formulation are listed below ... 

Spray-dried lactose in the formulation may be replaced by spray-dried mannitol such as Pearlitol SD100. Also, the ratio of the lactose to Avicel PH 102 should be optimized for required product quality attributes including blending uniformity, content uniformity, potency, drug release, and breaking strength. 

Bauer H, Herkert T, Bartels M. 2000. Investigations on polymorphism of mannitol/sorbitol mixtures after spray drying using different scanning calorimetry, X-ray diffraction and near infrared spectroscopy. Pharm. Ind. 62(3) 231-235. 

Powders intended for nasal administration have to be optimized in terms of particle size and morphology as these properties are related to potential irritation in the nasal cavity [23], Certain procedures (e.g., spray drying process) can modify the particle size of the drug powder raw material, but in order to optimize the morphology and flowability properties of some pure drug powders, excipients need to be used. Sacchetti et al. [28] reported that the use of mannitol as a filler and hydroxy-propylmethyl cellulose (HPMC) as a shaper of spray-dried caffeine microparticles modified the typical needle shape of spray-dried caffeine to a more convenient roundish shape. Further addition of polyethylene glycol (PEG) resulted in increased... 

Excipient manufacturers are now supplying excipients specifically geared toward manufacture of ODTs. One of them is spray-dried mannitol. The properties of this excipient suitable for ODTs include good compressibility at low hardness and fast disintegration, desirable properties for the manufacture of ODTs. The two brands commercially available include Pharmaburst by SPI Pharma and Pearlitol by Roquette. The hope is that it will stimulate the development of ODTs in house for pharmaceutical companies not traditionally involved with manufacture of ODTs. 

Nuguru KS, Giambattislo D, Al-Ghazawi AK. Evaluation and characterization of spray-dried mannitol as an excipient for direct copression formulations of naproxen sodium. AAPS Pharm Sci 2001 3 Abstract available from http //www.aapspharmsci.CH g/... 

The effect of processing technique on the aerosol performance of insulin formulations prepared by DG antisolvent precipitation and spray drying has been investigated. Two types of insulin formulations were produced. They were 1 20 insulin-mannitol (IM) and 1 20 8 insulin-mannitol-citric acid (IMC). Mannitol is an excipient commonly used to improve aerodynamic performance of powders for inhalation delivery. Citric acid has been found effective in improving insulin absorption in the lungs. ... 

Dense gas IM samples were precipitated from dimethylsulfoxide solutions using carbon dioxide as an antisolvent, while spray dried products were generated from insulin suspensions in mannitol aqueous solutions. Dense gas and spray dried IMC samples were produced from aqueous solutions in the DG antisolvent process carbon dioxide modified with ethanol was used as an antisolvent. The particle size of DG processed formulations was substantially larger than the corresponding spray dried material for both IM and IMC samples 21.8 vs. 5.71pm and 11.9 vs. 7.24pm, respectively, as measured by laser diffraction of the dry powders. The aerosol performance of DG processed IMC formulations, however, was superior to the spray dried counterpart, as measured by impactor studies. In fact, the RF of the DG processed IMC was 47.6%, while spray dried IMC had an RF of 30.0%. The aerosol performance of IM samples followed an opposite trend with the DG product exhibiting an RF of 26.6% and the spray dried of 30.6%. ... 

---