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Preparation and characterization of etoricoxib solid dispersions using lipid carriers by spray drying technique.

The basic objectives of this study were to prepare and characterize solid dispersions of poorly water-soluble drug etoricoxib using lipid carriers by spray drying technique. The properties of solid dispersions were studied by diffuse reflectance infrared Fourier transform spectroscopy (DRIFTS), differential scanning calorimetry (DSC), hot-stage microscopy (HSM), radiograph powder diffraction (XRPD), and dissolution studies. The absence of etoricoxib peaks in XRPD profiles of solid dispersions suggests the transformation of crystalline etoricoxib into an amorphous form. In the HSM examination of solid dispersions, the dissolution of drug in the lipid carriers was observed, which was also confirmed by the absence of etoricoxib peak in DSC curves of solid dispersions. The DRIFTS spectra revealed the presence of hydrogen bonding in solid dispersions. The in vitro dissolution test showed a significant increase in the dissolution rate of solid dispersions as compared with pure etoricoxib, spray-dried etoricoxib, and physical mixtures of drug with lipid carriers. Therefore, the dissolution rate of poorly water-soluble drug etoricoxib can be significantly enhanced by the preparation of solid dispersions using lipid carriers by spray drying technique.

Chemistry, Pharmaceutical↗

The effect of process and formulation variables on the properties of spray-dried beta-galactosidase.

The objective of this study was to evaluate the joint effects of various processing and formulation variables on the properties of spray-dried beta-galactosidase using statistically designed experiments. The key response variables evaluated were product yield, residual enzymatic activity, moisture content and particle size and appearance. The residual enzymatic activity and product yield were significantly affected by the processing variables. The highest product yields were obtained when the drier outlet temperature was relatively high, resulting in extensive protein denaturation. Subsequent experiments, therefore, compared the relative effectiveness of four stabilizers (mannitol, sucrose, arginine hydrochloride and trehalose) in terms of their ability to preserve enzymatic activity during the spray-drying process and during long-term storage. Trehalose was the most suitable stabilizer. The effect of a number of other formulation variables (total solids level, ratio of stabilizer to protein, presence of surfactant and presence of buffer) was also investigated. A final formulation consisting of 6% beta-galactosidase and 10% trehalose in deionized water was selected. Spray-drying at inlet and outlet temperatures of 140 and 95 degrees C, respectively, results in greater than 70% yields of a fully active product with a moisture content of 2-5% and a mean particle size of 2-4 microns.

Arginine↗

Spray dried powders and powder blends of recombinant human deoxyribonuclease (rhDNase) for aerosol delivery.

PURPOSE: We have used rhDNase to investigate the feasibility of developing a dry protein powder aerosol for inhalation delivery. METHODS: Powders of rhDNase alone and with sodium chloride were prepared by spray drying. Powder blends were obtained by mixing (tumbling and sieving) pure rhDNase powder with 'carrier' materials (lactose, mannitol or sodium chloride). The weight percent of drug in the blends was between 5 and 70%. The particle size distributions and crystallinity of the spray dried powders were obtained by laser diffraction and X-ray powder diffraction, respectively. Particle morphology was examined by scanning electron microscopy. The ability of the powders and powder blends to be dispersed into respirable aerosols was measured using a Rotahaler connected to a multistage liquid impinger operating at 60 L/min. RESULTS: Pure rhDNase powder was quite cohesive with a fine particle fraction (FPF or "respirable fraction': % wt. of particles < 7 microns in the aerosol cloud) of about 20%. When particles also contained NaCl, the powders were dispersed better to form aerosols. A linear relationship was observed between the NaCl content and FPF for a similar primary size (approximately 3 microns volume median diameter) of particles. The particle morphology of these powders varied systematically with the salt content. For the blends, SEM revealed a monolayer-like adhesion of the fine drug particles to the carriers at drug contents > or = 50% wt. An overall 2-fold increase in FPF of rhDNase in the aerosol cloud was obtained for all the blends compared to the pure drug aerosols. CONCLUSIONS: The aerosol properties of spray dried rhDNase powders can be controlled by incorporation of a suitable excipient, such as NaCl, and its relative proportion. Coarse carriers can also enhance the performance of rhDNase dry powder aerosols.

Aerosols↗

Particle design of three-component system for sustained release using a 4-fluid nozzle spray-drying technique.

We prepared composite particles of acetaminophen (Act) with chitosan (Cht) and hydroxypropylmethylcellulose phthalate (HPMCP) as a carrier using a newly developed 4-fluid nozzle spray-dryer. Cht dissolves in acid solutions and forms a gel, but it is insoluble in alkaline solutions. On the other hand, HPMCP is insoluble in acid solutions, but it dissolves in alkaline solutions. Therefore, we tested a preparation of controlled release composite particles using the characteristics of these carriers. Act and Cht mixtures in prescribed ratios were dissolved in an acid solution. Composite particles of Act and HPMCP in prescribed ratios were dissolved in alkaline solutions. We evaluated the composite particles of the three components (Act, Cht, and HPMCP) by preparing solid dispersions using a 4-fluid nozzle spray-dryer. Observation of particle morphology by scanning electron microscopy (SEM) revealed that the particles from the spray-drying process had atomized to several microns and had all become spherical. We investigated the physical properties of the composite particles by powder X-ray diffraction, differential scanning calorimetry, and dissolution rate analysis to clarify the effects of crystallinity on the dissolution rate. Powder X-ray diffraction peaks and the heat of fusion of Act in the spray-dried samples decreased in proportion to the carrier content, indicating that the drug was amorphous. These results indicate that the Act-Cht-HPMCP system formed a solid dispersion. Furthermore, we investigated the interaction between the drug and the carrier using FT-IR analysis. FT-IR spectroscopy of the Act solid dispersions suggested that the Act carbonyl and Cht amino groups formed a hydrogen bond. On the other hand, interaction by hydrogen bond was observed between the carbonyl group of HPMCP with the amino group of Act. In the three-component Act-Cht-HPMCP system, the 4-fluid nozzle spray-dried preparation with a mixing ratio of 1 : 2.5 : 2.5 obtained sustained release preparation in all pH test solutions.

Acetaminophen↗

Particle design using a 4-fluid-nozzle spray-drying technique for sustained release of acetaminophen.

We prepared matrix particles of acetaminophen (Act) with chitosan (Cht) as a carrier using a newly developed 4-fluid-nozzle spray dryer. Cht dissolves in acid solutions and forms a gel, but it does not dissolve in alkaline solutions. Therefore, we tested the preparation of controlled release matrix particles using the characteristics of this carrier. Act and Cht mixtures in prescribed ratios were dissolved in an acid solution. We evaluated the matrix particles by preparing a solid dispersion using a 4-fluid-nozzle spray dryer. Observation of the particle morphology by scanning electron microscopy (SEM) revealed that the particles from the spray drying process had atomized to several microns, and that they had become spherical. We investigated the physicochemical properties of the matrix particles by powder X-ray diffraction, differential scanning calorimetry, and dissolution rate analyses with a view to clarifying the effects of crystallinity on the dissolution rate. The powder X-ray diffraction peaks and the heat of the Act fusion in the spray-dried samples decreased with the increase of the carrier content, indicating that the drug was amorphous. These results indicate that the system formed a solid dispersion. Furthermore, we investigated the interaction between the drug and carrier using FT-IR analysis. The FT-IR spectroscopy for the Act solid dispersions suggested that the Act carboxyl group and the Cht amino group formed a hydrogen bond. In addition, the measurement results of the 13C CP/MAS solid-state NMR, indicated that a hydrogen bond had been formed between the Act carbonyl group and the Cht amino group. In the Act-Cht system, the 4-fluid-nozzle spray-dried preparation with a mixing ratio of 1 : 5 obtained a sustained release preparation in all pH test solutions.

Acetaminophen↗

Stability of spray-dried tuna oil emulsions encapsulated with two-layered interfacial membranes.

omega-3 Fatty acids have numerous health benefits, but their addition to foods is limited by oxidative rancidity. Spray-drying tuna oil-in-water emulsion droplets with a coating of lecithin and chitosan multilayer system could produce emulsion droplet interfacial membranes that are cationic and thick, both factors that can help control lipid oxidation. Physicochemical and oxidative stability of the spray-dried emulsions were determined as a function of storage temperature and relative humidity (RH). The combination of ethylenediaminetetraacetic acid (EDTA) and mixed tocopherols was able to increase the oxidative stability of dried emulsions. Lipid oxidation was more rapid during storage at low relative humidity (11% and 33% compared to 52% RH). At high moisture, physical modifications in the sample were observed, including reduced dispersibility and formation of brown pigments. Sugar crystallization or Maillard products produced at the higher humidities may have inhibited oxidation. Overall, spray-dried tuna oil-in-water emulsions stabilized by lecithin-chitosan membranes were more oxidatively stable than bulk oils and thus have excellent potential as an omega-3 fatty acid ingredient for functional foods.

Animals↗

Spray dried excipient base: a novel technique for the formulation of orally disintegrating tablets.

Orally disintegrating tablets (ODT) are gaining popularity over conventional tablets due to their convenience in administration and suitability for patients having dysphagia. Moreover no water is required for swallowing the tablets and hence suitable for geriatric, pediatric and traveling patients. The purpose of this study is to assess the suitability of spray dried excipient base in the formulation of ODTs of Valdecoxib (low aqueous solubility) and Metoclopramide (high aqueous solubility). Spray dried excipient base was prepared using Scientech spray drier. Super disintegrants (such as Ac-Di-Sol, Kollidon CL, sodium starch glycolate), diluent (mannitol) alongwith sweetening agent (aspartame) were used in the formulation of tablets. The tablets were evaluated for hardness, friability, water absorption ratio, disintegration time (DT) and in vitro drug release. Using the same excipients, the tablets were prepared by direct compression and were evaluated in the similar way. Maximum drug release and minimum DT were observed with Kollidon CL excipient base as compared to tablets prepared by direct compression, showing the superiority of the spray dried excipient base technique over direct compression technique.

Absorption↗

Encapsulation of ethanol by spray drying technique: effects of sodium lauryl sulfate.

Microcapsules composed of ethanol, water and dextrin as a water-soluble polymer can be used to encapsulate poorly water-soluble drugs by spray drying technique. For the encapsulation of a high dose of poorly water-soluble drugs, large amounts of ethanol and consequently large quantities of dextrin are needed for the dissolution of drug and the encapsulation of ethanol, respectively. In order to increase the ethanol content with the decreased amount of dextrin, sodium lauryl sulfate (SLS) was employed in the preparation of microcapsules without drug by a spray drying method. Phase diagrams were prepared to determine the region of microcapsule formation with a three-component system of ethanol, dextrin and water. The homogeneous phase indicated in the phase diagram was used to prepare the alcoholic microcapsules since this phase was not separated rapidly and not too viscous to be spray-dried. Interestingly, SLS at concentrations below 2% remarkably increased both the ethanol content and the encapsulation efficiency of ethanol. The maximum ethanol content and encapsulation efficiency were observed with 0.5-1% of SLS (35.4 and 67.6%, respectively). Furthermore, the increase by SLS was more pronounced at the low dextrin/water ratios than at the high dextrin/water ratios. In particular, the ethanol content and the encapsulation efficiency with the dextrin/ethanol/water ratio of 0.4/1/1, which had relatively small amounts of dextrin, were about ten times higher in the presence of SLS than those without SLS. In conclusion, this study shows that small amounts of SLS can increase the ethanol content and the encapsulation efficiency of ethanol, and allow the reduction in the amount of dextrin required to encapsulate ethanol in the preparation of microcapsules. These findings suggest that the use of SLS may permit the effective encapsulation of high dose of water-insoluble drug into microcapsules.

Capsules↗

Droplet and particle size relationship and shell thickness of inhalable lactose particles during spray drying.

To find means of controlling the size and density of particles intended for inhalation the relationship between droplet and particle size during spray drying was investigated. Lactose solutions were atomized with a two-fluid nozzle and dried in a laboratory spray drier. The effects of nozzle orifice diameter, atomization airflow and feed concentration on droplet and particle size were examined. Mass median diameter of both droplets and particles were analyzed with laser diffraction. In addition, scanning electron microscopy and transmission electron microscopy were used for studies of particle shape and morphology. It was demonstrated that nozzle orifice diameter and airflow, but not feed concentration controlled the droplet size during atomization. Increasing droplet size increased particle size but the effect was also influenced by feed concentration. Particles from solutions of a low concentration (1% w/w) were smaller than those from higher concentrations (5-20% w/w). This may be partly explained by lower yields at higher feed concentrations, but may also be related to differences in drying rate. Spray-dried lactose solutions formed hollow particles, and it was suggested that the shell thickness of the particles increased with increasing feed concentration.

Administration, Inhalation↗

Influence of adjuvants on the dissolution profile of tablets containing high doses of spray-dried extract of Maytenus ilicifolia.

A 2(3) factorial design was used in order to evaluate the influence of some adjuvants on the dissolution profile of tablets containing high doses of Maytenus ilicifolia spray-dried extract. Tablets were prepared on a single punch tablet press using 15 mm flat punches by individual direct compression of 650 mg from each formulation containing 375 mg of the spray-dried extract. The factors investigated were disintegrant (croscarmellose sodium or sodium starch glycolate), lubricant (colloidal silicon dioxide or magnesium stearate) and filler/binder (microcrystalline cellulose or lactose). The dissolution profiles were analyzed to determine the dissolution kinetics, the dissolution half-lives (t50%), the similarity factor (f2) and the dissolution efficiency (DE %), which was selected as the response criteria to evaluate the factorial design. The results revealed that in spite of the high content of spray-dried powder in the tablets, the dissolution profiles of the extract did depend on the adjuvant used. The filler/binder had the most important effect on the dissolution efficiency of the tablets.

Adjuvants, Pharmaceutic↗

[Spray-dried plasma in diets for weaned piglets: influence on growth and underlying mechanisms].

Spray-dried animal plasma (SDAP) is a by-product of slaughter plants. The plasma obtained from slaughtered pigs or ruminants is spray-dried and used for the production of human foodstuffs and animal feeds. SDAP added to the diet of weaned piglets has considerable positive effects on the growth performance of piglets. In a meta-analysis, it was calculated from 68 comparisons between SDAP-containing diets and control diets that the SDAP-induced change in average daily gain (ADG) and average daily feed intake (ADFI) in the first 2 weeks after weaning was +26.8% and +24.5%, respectively. Two experiments demonstrated that dietary SDAP can reduce post-weaning diarrhoea. The aim of the research described in this thesis was to learn more about the mechanisms underlying the growth- and health-promoting properties of SDAP in the diet of weaned piglets. Results showed that dietary SDPP has positive effects on the post-weaning growth performance and health of piglets. These effects are more pronounced in piglets kept under suboptimal conditions and/or high infection pressure, and in piglets fed on diets lacking anti-microbial growth promoters. SDAP acts by influencing the gastrointestinal microflora: it appears to affect pathogenic bacteria rather than exert a general anti-bacterial effect leading to nutrient sparing, as has been described for anti-microbial growth promoters. SDAP has great potential as treatment for immuno-compromised mammals, such as neonates, and for animals in which antibiotic treatment is not possible, for instance when there is a ban against antibiotics or when multi-resistant bacteria are involved.

Animal Feed↗

Encapsulation of plasmid DNA in PLGA-stearylamine microspheres: a comparison of solvent evaporation and spray-drying methods.

Stearylamine, a positively charged hydrophobic molecule, was tested as a formulation agent for the encapsulation of a model plasmid in PLGA microspheres. The primary objective was to compare the spray-drying and double emulsion solvent evaporation methods and evaluate their suitability for fabricating PLGA-stearylamine plasmid-entrapped microspheres. A luciferase reporter gene plasmid (pGL3-Con) was formulated into microspheres using a 64 kDa PLGA 50:50 polymer blended with stearylamine (SA) at a range of concentrations up to 15%m/m, by the solvent evaporation and spray-drying methods. The microspheres were characterized regarding their size distributions, zeta potentials and morphology by laser diffraction, electrophoretic mobility and scanning electron microscopy (SEM), respectively. Formulated plasmid extracts were assessed for physical damage by agarose gel electrophoresis, and the in vitro biological activity was determined by transfection of a human embryo kidney epithelial (293) cell line. Size distribution analysis showed that SA reduced the median diameters of spray-dried particles from 8.32 to 3.64 microns, with a corresponding reduction in the spread of the distribution, but solvent evaporation microspheres showed an increased median diameter on addition of SA. Concentrations of SA above 10%(m)/(m) resulted in disruption of the smooth morphology of the solvent evaporation particles. There was a SA concentration-dependent tendency in the increase of surface positive charge and resistance to serum nuclease assault and in vitro expression of luciferase protein. These results show that SA and possibly other charged hydrophobic molecules may be useful agents in the formulation of particulate DNA vaccines by both methods.

Amines↗

Effects of spray-dried animal plasma on intake and apparent digestibility in dogs.

Effects of spray-dried animal plasma (SDAP) on intake and apparent digestibility of major dietary components were determined using 22 adult Beagles. Trials 1 and 2 used six and eight dogs, respectively, in a switchback design using 10-d periods. Trial 3 used eight dogs in a replicated 4 x 4 Latin square design with 15-d periods. The final 5 d of each period were used for measurement of intake and fecal collections. In Trial 1, dry extruded dog food kibbles were coated with 5% tallow, 2% commercial flavor, and 0 or 2% SDAP (as-fed basis). In Trial 2, commercially available dry dog food, previously coated with fat and flavor were coated with 0 or 2% SDAP. In Trial 3, SDAP (0, 1, 2, or 3%) was blended with other ingredients and extruded (as-fed basis). Kibbles were subsequently coated with 5% poultry fat and 1% commercial flavor. Intake, fecal consistency, and apparent digestibility of nutrients were determined. Addition of SDAP did not markedly affect chemical composition of diets and did not affect intake. Digestibility of DM was improved (P < 0.04) an average of 3.2% when 2% SDAP was included in the diet for all trials. Organic matter digestibility was improved (P < 0.01) in Trials 2 and 3 by an average of 2.9%. Also, digestibility of crude fiber (Trials 1 and 2) or total dietary fiber (Trial 3) was increased with addition of SDAP to the diet (P < 0.01). Fecal DM excretion was decreased by an average of 15% across all trials with the addition of SDAP. Spray-dried animal plasma was an acceptable ingredient in dry dog food preparations, resulting in improved digestion and decreased fecal output. Changes in digestion that occurred with addition of SDAP suggested alteration in digestive capacity in dogs.

Animal Feed↗

Spray-dried lactose composite particles containing an ion complex of alginate-chitosan for designing a dry-coated tablet having a time-controlled releasing function.

PURPOSE: The properties of novel spray-dried lactose composite particles suitable for the coating filler of a dry-coated tablet having a long induction period in drug release were investigated. METHODS: To prepare spray-dried composite particles containing alginate-chitosan complex (SD(L/AL-CS)), an aqueous solution of lactose and sodium alginate and the acetic acid solution of chitosan were concomitantly fed into the rotary atomizer of a spray-dryer. The formation of the alginate-chitosan complex was confirmed by measuring the weight of insoluble portion in the mixture of sodium alginate and chitosan solutions. The dissolution properties of the dry-coated tablet were measured with the JP specified paddle method. RESULTS: The micromeritic properties of SD(L/AL-CS) were compared to those of the SD composite particles of lactose-sodium alginate, having a good compacting property. The drug release profiles of dry-coated tablet with SD(L/AL-CS) contained a long induction period followed by a rapid drug release phase in the artificial intestinal fluid. The induction period for drug release to occur was increased with an increase in the degree of deacetylation of chitosan and in the amount of chitosan in the formulation. The prolongation of induction period was attributed to the formation of an insoluble ion complex between sodium alginate and chitosan in the composite particles, which could form a rigid gel structure on the tablet surface. CONCLUSIONS: A time-controlled release tablet was designed with the composite particles of lactose containing the alginate-chitosan ion complex. The induction period of the dry-coated tablet could be prolonged in order to deliver the drug to the colon by controlling the type and amount of chitosan formulated in the composite particles.

Alginates↗

Effects of spray-dried animal plasma and immunoglobulins on performance of early weaned pigs.

Five experiments were conducted to evaluate the effects of dietary spray-dried porcine plasma (SDPP) and spray-dried bovine plasma (SDBP) and their various molecular weight fractions on performance of pigs weaned at approximately 14 or 21 d of age. In addition, the efficacy of various levels of the immunoglobulin G (IgG)-rich fraction of SDPP and SDBP were evaluated. Experiment 1 evaluated the dietary addition of SDPP and three of its fractions (IgG-rich, albumin-rich, and low molecular weight fractions). Pigs fed SDPP grew faster and consumed more feed than the controls during the first week (P < 0.05). The IgG-rich fraction resulted in improvements in ADG and ADFI that were similar to those of pigs fed SDPP. The albumin-rich fraction had no effect on growth rate, but the low molecular weight fraction decreased feed intake as well as growth rate. Experiments 2 and 3 evaluated SDPP and graded levels of its IgG-rich fraction in pigs weaned at 21 or 14 d, respectively. In Exp. 2, pigs fed SDPP grew faster and consumed more feed than the controls during the first week (P < 0.05). Pig performance was enhanced with the addition of the IgG-rich fraction that provided 80% of the amount of IgG in the SDPP diet. In Exp. 3, there was no response to SDPP during the first week, but a positive growth response to SDPP (P < 0.01) occurred by the end of wk 2 (0 to 14 d). Feeding the IgG-rich fraction increased growth rate compared with controls (P < 0.05). Over the entire experiment, the greatest ADG occurred with the IgG-rich fraction that provided 128% of the amount of IgG provided by SDPP (quadratic; P < 0.05). Two additional experiments assessed feeding SDBP and bovine IgG-rich fractions to early weaned pigs. In Exp. 4, SDPP was superior to SDBP in stimulating growth and feed intake, but this difference did not occur in Exp. 5. In both experiments, the IgG fraction of bovine plasma seemed to be as effective at improving growth as SDPP and more effective than SDBP. The results indicate that both porcine and bovine plasma are beneficial to young pig performance during the first week after weaning and that the IgG fraction of plasma is the component that is responsible for the enhancement in growth rate and feed intake.

Animal Feed↗

Acetaminophen particle design using chitosan and a spray-drying technique.

In this study matrices were prepared from particles of poorly water-soluble drugs such as acetaminophen (Act) to determine the drug release rate from these matrix particles. The matrix particles were prepared by incorporating drugs into chitosan powder (Cht, carrier) using a spray-drying method. The formation of composite particles was confirmed by scanning electron microscopic (SEM) analysis. The matrix particles prepared by spray-drying were spherical with a smooth surface. The crystallinity of acetaminophen in the composite particles was evaluated by powder X-ray diffraction and differential scanning calorimetry (DSC). The degree of crystallinity of acetaminophen in the matrix particles decreased with a reduction in the weight ratio of acetaminophen relative to the carrier. These results indicate that a solid dispersion of acetaminophen in chitosan forms matrix particles. The interaction between acetaminophen and chitosan was also investigated by FT-IR analysis. FT-IR spectroscopy of the acetaminophen solid dispersion suggested that the carbonyl group of acetaminophen and the amino group of chitosan formed a hydrogen bond. There were some differences at pH levels of 1.2 and 6.8 in the release of acetaminophen from the physical mixture compared to the matrix particles. At pH 1.2, the release from the matrix particles (Act : Cht=1 : 5) was more sustained than from the physical mixtures. The 70% release time, T70, of acetaminophen from the matrix particles (Act : Cht=1 : 5) increased in pH 1.2 fluid by about 9-fold and in pH 6.8 fluid by about 5-fold compared to crystalline acetaminophen. These results suggest that matrix particles prepared by spray-drying are useful as a sustained release preparation.

Acetaminophen↗

Acceptability, safety, and digestibility of spray-dried bovine serum added to diets of recovering malnourished children.

BACKGROUND: Specially collected, spray-dried bovine and porcine blood plasma have been incorporated previously in feeds of weanling farm animals, resulting in increased dietary intakes and greater rates of weight gain than observed in control animals. Before conducting similar trials in human populations, preliminary studies have been completed to assess the acceptability, safety, and digestibility of processed animal plasma in young children. METHODS: Masked study diets were provided sequentially to each of ten young, Peruvian children recovering from severe protein-energy malnutrition during three randomly ordered 7-day dietary periods. The control diet was prepared from rice, milk, vegetable oil, and sugar; the two study diets included spray-dried, bovine serum concentrate to replace either 25% or 50% of the milk protein of the control diet. Urine and feces were collected quantitatively during the last four days of each diet period to assess stool weight, apparent absorption of macronutrients, and retention of nitrogen. RESULTS: All children consumed the entire amounts offered of each of the diets. The mean number of daily bowel movements and mean apparent absorption and retention of nitrogen and mean apparent absorption of carbohydrate were similar for each diet. Fractional absorption of dietary lipid and of total energy increased significantly in relation to the amount of bovine serum concentrate in the diet, although this might be explained by the simultaneous replacement of milk fat with additional vegetable oil. CONCLUSIONS: Each of the diets was well accepted by the study children, and there was no evidence of any adverse effects of bovine serum concentrate.

Animals↗

Plasticizers and their effects on microencapsulation process by spray-drying in an aqueous system.

Microencapsulated theophylline particles were prepared by an aqueous spray-drying process using hydroxypropylmethylcellulose. The effect of different plasticizers, triethylcitrate, polyethylene glycol, propylene glycol, glycerin and citric acid, was investigated. Triethylcitrate, a water-insoluble plasticizer, produced a porous honeycomb-like microcapsule wall resulting in rapid drug release. The presence of the plasticizers also influenced crystallization of the drug. The formation of a solid drug dispersion was observed with the addition of citric acid or glycerin. Changes in the pH of liquid feed caused by the plasticizer had an effect on the product dissolution profile, but this was not a major factor. Formation of pores due to leaching of plasticizers during dissolution enhanced drug release. Flow property measurements indicated that the plasticizers also affect the cohesiveness of the spray-dried products. Compared to the microcapsules formed without any plasticizers, propylene glycol, glycerin and citric acid appeared to be beneficial to the microcapsule wall formation, with microcapsules containing citric acid having the slowest drug release.

Crystallization↗