OBJECTIVES The objective of this paper is to elaborate problematics of development and industrial aspect of lipid based nanotherapeutics in the form of solid lipid nanoparticles. Topic will be elaborated within existing regulatory guidance and available literature. Solid lipid nanoparticles are chosen as area of great industry and scientific interest and for the fact that these are biologically compatible systems that have big span of modifications that can be produced by standard manufacturing methods, in comparison to other types of therapeutic nanosystems. MATERIALS AND METHODS The literature is searched by research subject (keywords; lipid, nanotherapeutic, solid lipid nanoparticles, drug delivery), known authors in this area (Müller, Shah) and journals (J. Control Release, Adv. Drug Deliv. Rev., Int. J. Pharm.).Bibliographic database (PubMed) and database with full text (Science Direct) were researched. The literature is searched from general to specialized articles whereby only articles that are relevant for this subject were chosen. As well, this paper also covers analysis of annual reports and guidance published by headmost regulatory agencies as European Medicines Agency (EMA) and US Food and Drug Administration (FDA). Definition of terms was used as published in Medicinal Products Act (Official Gazette No. 76/13), Agency for Medicinal Products and Devices (HALMED). RESULTS Solid lipid nanoparticles (SLN) are safe and efficient form of lipid nanoparticles for the purpose of bioavailability enhancement of low soluble drugs. Selection of appropriate preparation method depends of physicochemical characteristics of drug and lipid and targeted particle size required to achieve. All these preparation methods depend on two critical processes; emulsion formation and particles dispersion in water solution to enable lipid or/and drug crystallization. Control of critical process parameters like temperature, pressure and number of cycles can be used to achieve quality target product profile of SLN. SLN can be produced by standard manufacturing methods without use of organic solvents which is advantage to certain other therapeutic nanosystems. Detailed physicochemical characterization is necessary in the development of SLN with incorporated drug and to achieve physical stability of colloidal nanoparticles suspension. Structural complexity and particle size are making characterization a challenge; therefore multiple complementary analytical techniques are required to be employed. Particle growth, formation of gel structures, polymorphic transitions are most common problems to appear in SLN development therefore in order to avoid them, it is necessary to investigate conditions and circumstances under which there occur. Employing quality by design as concept establishes systematic approach to the development of the SLN-drug system through understanding of manufacturing process and the final product. CONCLUSION Lipid nanoparticles are safe and efficient form of drug carrier due to its biocompatibility with the physiological systems. Because of the nanometer size, these can pass through all important biological barriers by various transcellular mechanisms and bring drug to the site of action in its unchanged form, accompanied by reduced characteristic side effects which occur with administration of standard forms of therapy. SLN are first generation of lipid nanoparticles and present a great interest of industry because of simplicity of manufacturing methods and wide span of modifications. Depending on choice of starting materials and manufacturing method of SLN, it is possible to achieve immediate or modified (prolonged, delayed) release of drug from the system.