The development of the technology of preparation of a new, original, combined ointment containing izohydrafural, methyluracil and benzocaine

Abstract

Introduction: The pathogenesis and treatment of infected wounds continues to be a challenging problem and represents a considerable healthcare burden. An effective treatment of wound infection requires combined drugs, which may reduce time to healing and minimize impact on patients, healthcare systems and society.

The purpose of the study was to develop the technology of preparation of a new, original, combined ointment containing of izohydrafural, methyluracil and benzocaine. It aims to Associate the antibacterial action of izohydrafural, the regenerating action of methyluracil and the local anesthetic action of benzocaine. The active substances have been incorporated in different pharmaceutical excipients to develop the optimal formula of the combined ointment. It was established that the lipophilic excipients are the most optimal base for the technology of the ointment.

Materials and methods: It was used the active substances: izohydrafural, methyluracil and benzocaine, the excipients: vaseline, oleum vaselini, cetostearyl alcohol, polyethylene glycol 400 and purified water.

Discussion results: It is already known the antibacterial action of the original, active substance izohydrafural, which is a derivative of 5-nitrofuran with valuable insights into the treatment of infected wounds and not only. The polyvalent nature of the infection requires a complex treatment. That’s why the association of izohydrafural with regenerating substances and local anesthetics in the same pharmaceutical form, will solve the problems related to pain and term of regenerative process, facilitating the treatment of infected wounds.

The active substances have been incorporated into lipophilic and hydrophilic excipients to develop the manufacturing technology of the combined ointment. It was investigated 12 compositions according to general criteria of the preformulation of ointments. The lipophilic excipients proved to be the most optimal, due to the lipophilic nature of benzocaine and methyluracil. Izohydrafural was incorporated using the water in oil emulsion base: cetostearyl alcohol.

It was established the sequence of incorporation of the ingredients into the ointment. The technological process of preparation of the combined ointment contains the following steps: (1) Preparation of the active substances; (2) Preparation of the excipients; (3) Incorporation of the active substance into the base of ointment; (4) Quality control of the combined ointment; (5) Packaging of finished product.

Conclusion: It was developed the technology of preparation of a new, original, combined ointment containing izohydrafural, methyluracil and benzocaine, which will be the basis for the Technological Laboratory Regulation for manufacture of investigational series of product.