Розробка складу та технології капсульованого лікарського препарату на основі перги та меду порошкоподібного. Повідомлення 3.

B. Т. Kudrik; A. I. Тikhonov; О. S. Shpychak

doi:10.14739/2409-2932.2016.3.77930

Authors

B. Т. Kudrik National University of Pharmacy,
A. I. Тikhonov National University of Pharmacy,
О. S. Shpychak National University of Pharmacy,

DOI:

https://doi.org/10.14739/2409-2932.2016.3.77930

Keywords:

Ambrosia, Honey, Powder, Excipients, Technology, «Api-Immuno-Vit» Capsules, Immunomodulation

Abstract

Aim. To develop experimentally and to substantiate theoretically both in pharmaceutical and industrial conditions the technology of manufacturing for capsules with the immunomodulatory action (provisional name «Api-Immuno-Vit») basing on pharmacotechnological and physical-chemical studies. Also to study the effect of excipients, the residual moisture and the particle size of capsules on technological parameters of mixtures quality, as well as to substantiate the choice of the size for solid gelatin capsules.

Material and methods. The study objects were the experimental samples of the mixtures of «Api-Immuno-Vit» capsules with such active pharmaceutical ingredients (API) as bee pollen (DSTU 7074:2009, GOST 31776-2012) and honey powder (TU U 10.8-39834691-001:2015, as well as aerosil and mannitol, which were used as excipients.

Results. The pharmacotechnological tests of the experimental samples of the mixtures (particle size distribution, moisture content, fluidity, bulk density and tapped density, angle of repose, uniformity of mixing) were carried out using the conventional methods given in the State Pharmacopoeia of Ukraine.

The influence of particle size distribution of the granulate on technological parameters of the mixture quality in capsules has been studied. It has been found that the increase of residual moisture leads to decrease of fluidity, and therefore, the residual moisture of the mixture for encapsulation should be less than 1.5%. It has been also noted that during the experiment the presence of large and medium fractions is important for the particle size distribution since fluidity and the bulk density of the mixtures significantly reduce if the fine fraction in more than 30% in amount.

Сonclusions. The results of the experimental studies were used in developing the flowchart of «Api-Immuno-Vit» capsules manufacturing. Taking into account the physical-chemical properties and the pharmacotechnological tests the flowchart of manufacturing has been developed; the technological parameters of its manufacturing have been substantiated. The rational amount of excipients (moisturizers, antifriction substances, powdering agents), which are necessary for performing each technological stage, the sequence of their mixing, as well as the parameters affecting the quality and stability of the drug have been calculated, and the technology of «Api-Immuno-Vit» capsules has been tested in pharmacy and industrial conditions.

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