A Review on Solid Dispersion to enhance Technique for Poorly
Water-soluble Drugs and its Polymers
Manoj M. Raut, Akash G. Pawar, Madhuri T. Deshmukh*
Department of Pharmaceutics, Kashibai Navale College of Pharmacy,
Kondhwa (BK), Pune 411048, Maharashtra, India.
*Corresponding Author E-mail: rautmanoj941@gmail.com
ABSTRACT:
When developing novel medicinal formulations, the solubility of the components is one of the most crucial factors to take into account. Over the course of the last several years, there has been a substantial increase in the use of novel chemical entities that possess very low permeability and solubility. Utilising a solid dispersion has shown to be the most effective method for administering doses of medications that are not easily soluble in water. Solid dispersions in water-soluble carriers have garnered a lot of interest as a means of enhancing the solubility and bioavailability of drugs that are hydrophobic. Formulation scientists confront considerable challenges when seeking to boost the oral bioavailability of solid-dose medications. These challenges are caused by difficulties related to solubility. It is possible that overcoming these challenges will be rather challenging. There is a possibility that the rate at which solid dosage forms of pharmaceuticals that are very challenging to treat dissolve may restrict the amount of medicine that is absorbed from these forms. Therefore, in order to boost the solubility of drugs that are only moderately soluble, formulation experts are required to apply processes that involve solid dispersion. In the present day, researchers are investigating the possibility of using solid dispersion techniques in order to enhance the bioavailability and rate of dissolution of medications that have a high lipophilicity. These procedures not only result in the production of amorphous drug particles, but they also reduce the size of the particles and enhance their wettability. A wide range of hydrophilic carriers, including natural, natural modified carriers, natural carriers, synthetic carriers, and semi-synthetic carriers, are discussed on this page. The use of these carriers results in the formation of solid dispersions. Throughout this essay, the primary focus will be on the topic that is now being discussed. This article examines a method that is more effective in dispersing medicinal substances and polymers that are insoluble in water, with a particular emphasis on solid solutions.
KEYWORDS: Solid Dispersion, Poorly Water-Soluble Drugs, Polymers, Poor Permeability, Dosage Form, Hydrophobic Drugs, Bioavailability, Biopharmaceutical Classification System, Components, Hydrophilic Matrix, Binary Solid Dispersion
INTRODUCTION:
When it comes to the administration of medication, the oral route is the approach that is recommended and used the most often due to its ease of use and simplicity. It is possible that patients may immediately identify and perceive the process of administering medication to them in the form of drinking a dose form as being enjoyable. Patients are more likely to take their medicine as prescribed when it is administered orally, making oral medication distribution a preferable method of drug delivery over parenteral drug administration. The reason for this is that oral medication delivery is more effective than other methods. nothing except one item1 Oral administration of drugs is a common practice among patients. The fact that many medications are difficult to dissolve in water makes oral administration of these medications inappropriate. Solubility is a factor that has a significant impact on the absorption and dissolving qualities of a medication. The Biopharmaceutical Classification System was responsible for defining the four different pharmaceutical categories by taking into account the permeability and solubility properties of medications2. In accordance with the BCS, drugs that are classed as Class II and Class IV have a restricted ability to dissolve in water. Increasing the solubility of drugs that are administered by the BCS II and IV routes is the concern that presents the greatest challenge. A number of techniques are used, including but not limited to the following: solid dispersion, particle size reduction (including micronization and nanonization), salt production, pH modification, polymorph and pseudo-polymorph synthesis, complexation, and the utilisation of surfactants and co-solvents. Utilising solid dispersion is the strategy that is both the fastest and most accurate way to improve solubility capabilities.3
SOLID DISPERSION:
There are a variety of approaches that may be used to enhance solubility. The solubility of a chemical may be significantly improved by the use of solid dispersion. There are two primary components that are required in order to produce a solid dispersion product. These components are a hydrophilic matrix and a hydrophobic medicine. Amorphous materials are able to dissolve medications more quickly and use less energy to break up the crystal lattice8 solubility is improved to a greater extent. It is possible for medications to become more soluble and wettable when they are delivered in carriers that are hydrophilic. This brings us to the fourth segment4:
Types of Solid Dispersion:
· Binary Solid Dispersion: It consists of medication and a polymeric carrier.
· Ternary Solid Dispersion: A polymeric carrier, a surfactant, and a medication make up this mixture5.
· Surface Solid Dispersion: To increase its solubility, surface solid dispersion is made with polymers such polyethylene glycol, polyvinyl pyrrolidone, and polyvinyl pyrrolidone-vinyl acetate copolymer through fusion process6.
Different solid dispersion systems can be categorized according to their primary fast release mechanisms. solid dispersions into the six illustrative categories listed below7.
Based on their molecular arrangement,
· Type1- Simple eutectic mixture
· Type2-Amorphous precipitations in crystalline matrix.
· Type3-Solid solutions
· Type4-Glass suspension
· Type5-Glass solution.8
CLASSIFICATION OF SOLID DISPERSION ON THE BASIS OF RECENT ADVANCEMENT:
1. First generation solid dispersion: When attempting to produce solid dispersions, it is necessary to make use of crystalline carriers. In the beginning, sugars and urea were regarded by the scientific community as being the first crystalline carriers for solid dispersions. After being influenced by thermodynamic instability, the medication is then gradually delivered into the body in a gradual manner. A number of times9:
2. Second generation solid dispersion: These solid dispersions make use of amorphous carriers rather than crystalline ones of the same category. The use of polymeric carriers is necessary in order to accomplish the desired outcome of medicine molecular dispersion. Polymeric carriers may be classified into two distinct types, which are as follows
· Synthetic polymer – povidone, polyethylene glycols and polymethacrylates.
· Natural polymers – hydroxypropyl methylcellulose, ethyl cellulose, starch derivatives like cyclodextrin10.
3. Third generation solid dispersion: Amorphous polymers or surfactant carriers are included in each and every one of these solid dispersions, in addition to the other components that are available. When it comes to medications that are not very soluble, these tablets provide the highest potential bioavailability that may possibly be conceived of. Inulin and poloxamer 407 are two examples of solid dispersion surfactants that belong to the third generation respectively. Eleven, in all honesty11.
POLYMER USED IN SOLID DISPERSION:
The combination of ethylene glycol with ethylene oxide results in the formation of a chemical known as polyethylene glycol, or PEG for short. At the molecular level, a polyethylene oxide is defined as any polyethylene glycol that has a molecular weight that is more than 300, 00012.
Ethanolamine, serine, choline, inositol and inositol phosphate, and glycerol esters are all included in the category of phospholipid head groups that are often found. The modification of the terminal hydroxyl of glycerides with head groups that are coupled to phosphate provides the basis for the formation of phospholipids. During the crystalline phase transition, variations in the fluidity of a material occur as the temperature of the substance changes from gel to liquid. When fatty acyls are substituted at the first and second positions of the glycerol backbone, in addition to the existence of various head groups, multiple species are created. This is in contrast to the production of triglycerides. There is a relationship between the validity of aggregate materials and the solubility of phospholipids, however this connection goes beyond the chemical features of the aggregate materials. Monoacyl phospholipids are more effective than other types of phospholipids because they may form micelles13.
PVP is unable to be produced at higher temperatures because the melting process is not hot enough to produce the solid dispersions that are produced by the melt-method at those temperatures. Powdered VP has a molecular weight that ranges from 2500 to 3000000, depending on the individual14. This substance may be dissolved in a number of different solvents, such as ethanol, water, chloroform, and isopropyl alcohol, among others.
The amazing ability to freeze liquids is possessed by molecules that are referred to as cyclodextrins. Because of this ability, these compounds are able to improve their solubility, disguise their flavours, protect themselves against chemicals, and improve their handling ways15.
OBJECTIVE:
· The primary focus of this investigation will be on the approaches that have been created to enhance the solid dispersion procedures for pharmaceuticals and polymers that are insoluble in water.
· Classification of solid dispersion in the medium16.
· Drugs that are insoluble in water are the subject of research now being conducted in an attempt to make them more soluble17.
Research Methodology:
All of this information was discovered by us via the use of a number of different search engines, such as Web of Science, PubMed, Scopus, and Google Scholar. Only high-quality, widely read scientific publications that covered clinical trials were taken into account for this inquiry18. Also, these studies addressed clinical trials.
The degree to which a medication is able to dissolve in water is one of the most important factors that determines how effectively it is absorbed and how effective it is19. During the process of formulating a new product, one of the potential issues that might arise is a lack of water solubility20. The slow rate of dissolution and the drug's poor water solubility are the primary factors that contribute to the drug's restricted bioavailability inside the system of the body21.
An extensive variety of hydrophilic carriers are now being investigated by scientists as a result of the increased solubility of these molecules22.
Researchers are still confronted with the difficulty of making hydrophobic drugs more soluble and dissolve, despite the fact that the majority of the prescription pharmaceuticals that are now available on the market are relatively new23. In order to ensure that oral medications are absorbed and made as accessible as possible, it is necessary for them to dissolve in a watery medium, such as the fluid that is found in the stomach. Because of this, polymer matrices that are generated from a variety of sources have the potential to improve the bioavailability of drugs that are not highly water soluble, such as BCS classes II and IV substances24. As an immediate consequence of this constraint, a great number of alternate approaches to enhancing solubility have come into existence. Increasing the solubility of pharmaceuticals may be accomplished using a variety of methods25, including chemical, physical, and other approach methods. Every single one of the two is included in the first table in its entirety26.
Table 1: Techniques for solubility enhancement of poorly water-soluble drugs:
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Techniques for solubility enhancement 2-5 |
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Physical modification |
1. Reduction Particle size |
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a. Micronization b. Nanosuspension, |
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2. Modification of the crystal habit |
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3. Solid dispersions a. Eutectic mixtures b. Solid solutions c. Amorphous solid solutions d. Glass solutions and glass suspension e. Cryogenic techniques. |
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Chemical modification |
1. Change of pH, |
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2. Use of buffer, |
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3. Derivatization, |
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4. Complexation, |
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5. Salt formation. |
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Miscellaneous methods |
1. Supercritical fluid process, |
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2. Use of adjuvant like surfactant, solubilizers, cosolvency, hydrotropy, and novel excipients. |
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The production of solid dispersion particles is one of the most effective methods for increasing the solubility of substances. In their definition of solid dispersion systems, Chiou and Riegelman describe them as "the dispersion of one or more active ingredients in an inert carrier or matrix at solid state prepared by the melting [fusion], solvent, or melting-solvent method." According to what is said on page27, "solid dispersion systems contain active ingredients." When they make that comment, they are referring to this.
Additionally, the subject of increasing the oral bioavailability of water-insoluble drugs by the use of solid dispersion technology is explored in greater depth in this paper28. According to research that was made public by the pharmaceutical industry, some technologies that include solid dispersion have the potential to improve the solubility of drugs that are not water soluble. Increasing the solubility of drugs that are only moderately soluble in water may be accomplished by the use of several techniques such as salt production, cyclodextrin complexation, solvent solubilisation, and particle size reduction29. There is a significant failure in each and every one of these approaches. On the other hand, the substance's composition does not change much30.
When it comes to oral administration, dispersions provide a wide variety of processing and excipient choices, which are particularly beneficial for medications that are insoluble in water (table 2). As shown in Table 3, the development of solid dispersion technology has mostly concentrated on the creation of pharmaceuticals that have a high biological membrane permeability and a low water solubility for maximum effectiveness31. The process of dissolving a medication has the potential to slow down the rate at which it is absorbed. It is believed that if it were possible to make a medicine more soluble, the pace at which it is absorbed by living beings would be greatly accelerated. During the course of their study in 1995, Amidon and his colleagues made the discovery that BCS Class II drugs had a low solubility in water but had a high degree of permeability to cell membranes32. As a result, solid dispersion technologies have the potential to enhance the oral absorption and bioavailability of BCS Class II drugs when they are administered orally33.
Table 2: List of Poorly Soluble Drugs with Hydrophilic Carriers
|
Sr. No. |
Carrier |
Drug |
|
1 |
Polyethylene glycol (PEG) |
Griseofulvin |
|
2 |
Polyvinylpyrrolidone (PVP) |
Flufenamic acid |
|
3 |
Hydroxypropylmethylcellulose (HPMC) |
Albendazole, Benidipine |
|
4 |
Sorbitol |
Predinisolon |
|
5 |
Urea |
Ofloxacin |
Table 3: Different materials used as carriers for solid dispersions37
|
Class |
Example of carriers |
|
Sugars |
dextrose, Sucrose, Galactose, Sorbitol, Maltose, Xylitol, Mannitol, Lactose |
|
Acids |
Citric acid, Succinic acid |
|
Polymeric materials |
Polyvinylpyrrolidone (PVP), Polyethylene glycols (PEG), Hydroxypropyl-methylcellulose, Methylcellulose, Hydroxyethylcellulose, Hydroxypropylcellulose, Cyclodextrins, Pectin, Galactomannan |
|
Insoluble or enteric polymers |
Hydroxypropylmethylcellulosephthalate, Eudragit L-100, Eudragit S-100, Eudragit RL, Eudragit RS |
|
Surfactants |
Polyoxyethylene stearate, Polyoxyethylene stearate, Poloxamer 188, Deoxycholic acid, Tweens, Spans |
|
Miscellaneous |
Pentaerythritol, Pentaerythrityltetracetate, Urea, Urethane, Hydroxyalkylxanthins |
TYPE OF SOLID DISPERSION:
1. Eutectics.
2. Amorphous solid solutions.
3. Solid solution.
a. Continuous solid solution.
b. Discontinuous solid solution.
c. Substitutional solid solution.
d. Interstitial solid solution
4. Glass solution and suspension34.
1. Eutectics Mixtures:
A combination of two liquid substances that are entirely miscible with one another but are not totally solid is referred to as a eutectic mixture. This phenomenon is referred to as instantaneous solidification, and it occurs when two substances that have low solid-solid solution temperatures and high liquid miscibility’s combine while they are still in a liquid form35.
Figure 1: Eutectics mixtures
2. Amorphous solid solution:
The amorphous precipitation form of the drug is the one and only distinguishing characteristic that differentiates this one from other straightforward eutectic combinations36.
Figure 2: Amorphous solid solution
It is not feasible to change the fact that solid solutions are always one-phase, regardless of the relative proportions of the components that make up the solution. When a drug dissolves in solid solutions, the molecular dimensions of the medicine are lowered. The pace of dissolution is primarily governed by the rate of dissolution of the carrier37. The manner in which these solid solutions are miscible (continuous or discontinuous) and the distribution of solvate molecules (interstitial, amorphous, or substitutional) are the characteristics that set them apart from one another38.
a) Continuous solid solution: It is possible to construct a mixture that is miscible with the continuous solution by using any concentration of the ingredients that are present in the continuous solid solution. Taking this into consideration, it seems that the interaction between the two components is more robust than the relationship that exists between their individual molecules. Components have a difficult time dissolving in discontinuous solid solutions due to the restricted solubility of the components. According to Goldberg et al., the term "solid solution" should only be used in situations when there is a reciprocal solubility connection between the two components that is more than 5%. Because the usage of the term generates unique practical issues, this is the situation that has arisen.
Figure 3: Discontinuous solid solution
b) Discontinuous solid solution: In situations where the difference in size between the solvent and the solute is less than 15%15, substitution is a potentially viable option. It is possible for the solute molecules in typical solid solutions to either operate as an interposition between the solvent molecules or to replace the solvent molecules that are present inside the crystal lattice39.
Figure 4: Substitutional solid solution
c) Interstitial solid solutions: During the formation of an interstitial solid solution, molecules are responsible for filling the vacancies in the crystal lattice that are caused by the presence of a solvent. It is essential that the diameter of the instrument does not exceed 0.59 times that of the solvent40.
Figure 5: Interstitial solid solution
Solid Dispersion:
The process that occurs when active compounds are dispersed in a solid state by means of an inert matrix or carrier is referred to as solid dispersion. For example,41
Figure 6: Solid dispersion of polymer matrix.
CONCLUSION:
The solubility and bioavailability of a medicine are two qualities that have an impact on the therapeutic efficacy of the treatment. As indicated by the growing number of pharmaceutical candidates that are not highly water-soluble and the improvements in the creation of these dispersions, solid dispersions are becoming an increasingly important component in the process of enhancing the solubility of medicines. This is proven by the fact that the number of pharmaceutical candidates is increasing. One of the numerous advantages that solid dispersion carriers provide in comparison to other methods is that they are already being used as pharmaceutical excipients and do not need any safety studies to be conducted in order to evaluate their extent of effectiveness. For the purpose of enhancing the biological properties of these compounds, solid dispersions are produced via the use of novel techniques. It is essential to find solutions to problems with the instability of medications, the cost-effectiveness of the technology, and the scaling up of the process before this technology is commercialised. Increasing the solubility of a chemical may be accomplished by a number of different methods, one of which is the use of solid dispersion. The use of solid dispersion has been proven to have the potential to improve solubility, according to research carried out over the last ten years. Prior to the commercialisation of this method, it is necessary to find solutions to issues concerning the volatility of the drug, the cost-effectiveness of the method, and the scaling up of the method. In spite of the fact that further research is required before the solid dispersion procedure may be used in manufacturing, it is useful since it assists in making drugs that are not very soluble more soluble.
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Received on 14.03.2025 Revised on 23.08.2025 Accepted on 11.11.2025 Published on 15.04.2026 Available online from April 18, 2026 Asian J. Pharm. Res. 2026; 16(2):211-217. DOI: 10.52711/2231-5691.2026.00032 ©Asian Pharma Press All Right Reserved
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