Search Screening Algorithm of Herbal Medicines for Electro and Phonophoresis

 

D. V. Babaskin, T. M. Litvinova, L. I. Babaskina

Sechenov First Moscow State Medical University, Trubetskaya St., 8-2, Moscow, 119991, Russian Federation.

 

ABSTRACT:

In the modern market conditions, the process of creating new pharmaco-physiotherapeutic methods in the rehabilitation of patients, including medicinal electro- and phonophoresis, becomes much more complicated. In order to reduce the risk and to neutralize the market uncertainties when developing new methods, it is necessary to conduct a full-fledged screening of drugs, using marketing analysis methods. The goal is to develop the best possible search screening algorithm of herbal medicines for electro- and phonophoresis in the rehabilitation of patients. Object and methods. The object of the study was the search screening of herbal medicines for electro- and phonophoresis. The work is based on the methods of structural, comparative, systemic, and situational analyses. Results and Discussion. The proposed search screening algorithm consists of five stages. Its distinctive features are fractional, phased screening by tests, including a study of a physical factor (electric current, or ultrasound) and a herbal medicine on the background of the marketing environment monitoring, a constant focus on the target market trends and behavior; a parallel series of studies with the use of iterative procedures; the use of the well-established data bank to expand the range of medical services at the stages of growth and maturity in the life cycle; and the possibility of developing pharmaceutical products. Conclusion. The best possible search screening algorithm of herbal medicines for electro- and phonophoresis has been developed and substantiated, which can be used in the modelling of the creation of new rehabilitation methods, including preclinical and clinical studies.

 

 

INTRODUCTION:

In the modern market conditions, the process of developing new patients’ rehabilitation methods is significantly complicated. The search screening of active agents with pharmacological activity alone takes an average of three years, despite the use of expensive equipment, highly paid professionals, which entails very large expenses^1–2. According to experts, the cost of developing an innovative drug is from USD 1 to 11 billion^3–5, of which 24.8 % represent the expenses at search and preclinical studies stages². Moreover, investing huge amounts of money in the development of rehabilitation methods does not mean that a new, highly popular method will be obtained.

 

It is known that currently the largest cost item in developing new methods is just the cost of dead-end projects, which for various reasons have to be suspended despite the investment of funds in them at the search stages of development^6,7. Reducing risk and ensuring the success of the new rehabilitation methods can be achieved by conducting continuous systematic monitoring of the marketing environment, assessment of the relevance and significance of the developed method depending on the trends and behavior of the target market⁸.

 

The creation of integrated pharmaco-physiotherapeutic rehabilitation methods, for example, medicinal electro- and phonophoresis entails additional risks of the preliminary design of the individual components of the complex. Thus, the creation of herbal medicine for its combined use with a physical factor is disadvantageous to manufacturers because of the high costs of drug development and small sales volumes. The use of the medicine with several physical factors (e.g., electrophoresis and phonophoresis) complicates the search for medicinal plants with the desired properties of the active agents and the development of dosage form. Thus, it is preferable to carry out electrophoresis using aqueous solution, and phonophoresis – using the ointment or gel base. Therefore, when creating new rehabilitation methods, researchers try to use the available herbal medicines, the range of which is small. Moreover, it should be taken into account that the establishment of a pharmaco-physiotherapeutic method involves drug resistance to the action of a physical factor, the stability of pharmacological activity when used together with it, the existence of a reasonable dosage form, sufficient raw materials base and the necessary standardized quality indicators. All this greatly complicates the process of developing integrated patients’ rehabilitation methods.

 

The way out of this situation, in the authors' opinion, would be to conduct a full-fledged search screening of drugs, for their use in combination with physical factors, using the marketing analysis methods for the purpose of possible leveling of market uncertainty factors.

 

The work is aimed at developing the best possible search screening algorithm of herbal medicines for electro- and phonophoresis in the rehabilitation of patients.

 

OBJECTS AND METHODS:

The object of the study was the screening of herbal medicines for electro- and phonophoresis. The work is based on the methods of structural, comparative, systemic, and situational analyses. The screening process algorithm was developed by the system dynamics method, allowing the study of complex systems with the analysis of their individual elements and the interaction between them, including causal relationships, feedback loops, environmental effects, etc.⁹.

 

RESULTS AND DISCUSSION:

The construction of the search screening algorithm of herbal medicines for electro and phonophoresis (Figure 1) was based on the well-known conceptual principles of pharmaco-physiotherapy¹⁰, Good Laboratory Practice – GLP, Good Clinical Practice – GCP, Good Clinical Laboratory Practice – GCLP, Good Manufacturing Practice – GMP, laws of the Russian Federation "On the basis of health protection of citizens in the Russian Federation" No. 323-FZ dated 21.11.2011 (as amended on 03.08.2018), Federal Law “On the circulation of drugs” No. 61-FZ dated 12.04.2010 (as amended on 27.12.2018), and the state standards of the Russian Federation.

 

The proposed algorithm was characterized by the fractional phased screening by tests, including the study of the physical factor (electric current, or ultrasound) and herbal medicine amid constant systematic analysis of the marketing environment, research of the size, structure, and behavior of the target market, regular positioning and the competitiveness assessment of the evolving rehabilitation method. Such approach provides for the continuous orientation of the search screening on development trends and behavior of target segments of the end and intermediate consumers, regular communication with the market, and is driven by the possibility of termination of studies at any stage if a goal or idea is not promising, with minimal cost.

 

It should be borne in mind that the concept of the development of new pharmaco-physiotherapeutic rehabilitation method is based on the fact that it must answer the needs that emerge or persist to the moment when this method will be used in a medical organization. At the same time, two conceptual requirements should be applied: the ability to anticipate and actively form new needs; reduction of the time period between the advancement of an idea and introduction of a new rehabilitation method into clinical practice. The latter can be achieved, firstly, by reducing the duration of each of the search stages, secondly, by combination thereof, and not the results are combined, but the screening and development process, and thirdly, by the application of iterative procedures, i.e. the systematic return of the developed rehabilitation method from the subsequent stage to the previous one for further development. This allows to eliminate the errors and mistakes made in the previous stages; to implement additional features and options that have been revealed at later stages; and to consider new possibilities of scientific and technological progress. It is known that the use of iterative procedures represents a very effective means of improving the quality and competitiveness of new treatments.

 

The proposed search screening algorithm (Figure 1) is based on a systematic approach to the establishment of an integrated pharmaco-physiotherapeutic rehabilitation method. The development of a new method begins and ends with marketing research.

 

At the first stage, a situational analysis of the marketing environment is carried out to identify issues¹¹.

 

Search for ideas to create electro- and phonophoresis of the herbal medicine (second phase; Figure 1) can be carried out using traditional sources: fundamental and applied research of the impact of various physical factors and major groups of active substances of herbal medicines, the effect of physical factors and the pharmacognostic study of different species and genera of plants, as well as the traditional medicine experience.

 

Figure 1 Search screening algorithm of herbal medicines for electro- and phonophoresis

 

In the market economy, an additional source of ideas are the consumers who may be the end users – patients, and, to a greater extent, the intermediate consumers – doctors. The main idea (goal) of creating a new pharmaco-physiotherapeutic method, as a rule, is evaluated and selected by experts on the most important parameters for researchers using the qualitative or quantitative method.

 

At the third stage, the primary study of the nature and action of the physical factor, the active substances and the spectrum of the pharmacological activity of the vegetable raw materials, and the intended herbal medicine is carried out.

 

Based on the results of the primary research, designs (elaborated versions of ideas, expressed by concepts significant for consumers) of a new rehabilitation method can be formulated (clause 3.4; Figure 1). Evaluation of the plans anticipates their testing on groups of intermediate and final consumers using the survey method.

 

At the fourth stage, an in-depth and extensive study of the characteristics, parameters, properties and action of the physical factor, chemical composition, safety, specific action of the herbal medicine, dosage forms, as well as the mechanisms of interaction of the physical factor and the drug is carried out.

 

An important stage of the search screening of a new herbal medicine is the evaluation of the plant raw material base (clause 3.3; Figure 1). This is especially true when using wild-growing medicinal plants with the geographically limited area. Additional raw material load on the thickets of these plants may affect their reserves. In addition, special attention should be paid to the type of medicinal plant raw materials. Thus, the irrational harvesting of underground organs of perennial wild plants (roots, rhizomes) can lead to the depletion of their reserves.

 

Since the newly created pharmaco-physiotherapeutic rehabilitation method is a complex one, it is possible to conduct parallel studies of physical factors and herbal medicine (for example, clauses 3.1 and 3.2 or 4.1 and 4.2; Figure 1).

 

The proposed approach to the search screening of medicinal herbal remedies for electro- and phonophoresis suggests the possibility of creating parapharmaceutical products (dietary supplements, cosmetics, etc.) already after the third stage and investing profits from its use in further development.

 

The feature of creating a new rehabilitation method using the known herbal medicines or dosage forms is to reduce clauses 3.2, 3.3 and 4.2 (Figure 1), and also the opportunity to offer the market the results of the studies after the fourth stage, since the interest in biologically active additives and cosmetic products is currently quite high.

 

Under the proposed algorithm, at some stages of the search screening as a result of the evaluation and selection process, ineffective plans, positions for action, and dosage forms remain, which later at the stages of growth and maturity of the life cycle of the developed rehabilitation method can be used to expand the range of medical services and goods.

 

Marketing monitoring of the situation throughout the search screening includes the positioning of electro- and phonophoresis of herbal medicine and an assessment of their competitiveness.

 

The mandatory final (fifth) stage of the search screening when creating new pharmaco-physiotherapeutic rehabilitation methods is the marketing planning of further preclinical and clinical studies and marketing control, which allows to strictly regulate and coordinate the development process (Figure 1). When forming a marketing strategy, as a rule, the estimated volume of use of the medical service and sales of the herbal medicine, market size, financial costs for the further development of the method, the possible profit from the sale of the herbal medicine are calculated for the subsequent few years; the issues about the general approach to the distribution of a new rehabilitation method and a herbal medicine are considered; the marketing budget is drawn up during the first year of using the new method, taking into account the potential of the market, developers and medical organizations.

 

Separate elements of the proposed search screening algorithm have been tested in the development of electro-and phonophoresis of the phytocomplex in the rehabilitation of patients^{12, 13}.

 

CONCLUSION:

Thus, the best possible search screening algorithm of herbal medicines for electro- and phonophoresis in the rehabilitation of patients has been developed. Its distinctive features are fractional, phased screening by tests, including a study of a physical factor (electric current, or ultrasound) and a herbal medicine on the background of the marketing environment systematic analysis, a constant focus on the target market trends and behavior; a parallel series of studies with the use of iterative procedures; the use of the well-established data bank to expand the range of medical services at the stages of growth and maturity in the life cycle; and the possibility of developing pharmaceutical products.

 

The developed search screening algorithm can be used to model the processes of creating new rehabilitation methods that include preclinical and clinical studies.

 

ACKNOWLEDGEMENT:

The study was supported by the "Russian Academic Excellence Project 5-100".

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Received on 31.05.2019           Modified on 18.06.2019

Accepted on 03.07.2019         © RJPT All right reserved