Pharmaceutical technology

  

What is preformulation? what is preformulation studies? what is the basic object of preformulation ?

Answer:

preformulation :preformulation is divide from two words that is “pre” and “formulation”. In here “pre” means before and “formulation” means preparation of drugs. So preformulation may be defined as the process of optimizing a drug through the determination of physical and chemical properties. Which are considered important in formulation of safe, effective and stable dosage form.

Preformulation studies: preformulation studies is an investigation of the physical, chemical and Mechanical properties of drug substance to develop a safe, effective and stable dosage form thus it forms an integral part of the drug development process.

Basic objects of pre-formulation studies:

1. To establish the physiochemical properties of a drug for its stability for any desired dosage form.

 2. To determine the Kinetic rate for drug stability.

 3. To establish compatibility of any drug with formulation excipient for possible in interaction.

4. Preparation of safe, effective and stable dosage form with better therapeutic values.

5.  To provide a rational for formulation design.

 6. To support of pre-formulation or to support the need for Molecular modification

 

What do you mean by molecular Optimisation?

molecular Optimisation: Molecular Optimization is a process, by which the molecule are optimized. Molecular Optimization is very important point in the pre-formulation studies, by the molecular Optimization we can minimize the drug API, but the API gives perfect therapeutic effect. Molecular Optimization is on of the important point of Pharmaceutical Technology. By the molecular optimisation of a drug gives perfect pharmacological action, price cheap and very important characteristics. There are four main important step of molecular Optimisation.

1. Prodrug.

2. Salt.

3. Solvated form.

4. Analoges.

Now we discuss about them.

1.Prodrug: Prodrug is on of the important steps of drug molecule Optimisation. By the term of pro-drug we know that the drug which are pharmacologically inactive compound and it is converted into active compound by metabolism. The pro-drug are always amide and ester group. The example of prodrug: Erythromycin Estolate.

Salt: Salt are the important step of drug molecule Optimisation. although each of these modification approaches  has been proven beneficial the salt and prodrug approaches are the most common. Most salt of organic compounds are formed by the addition or removal of proton to from an ionized drug molecule. Which is then neutralized with a counter ion.

The example of salt: Ephedrine hydrochloride.

Solvated from:

 It is also one kind of drug molecule optimised. In here some various solvents are added to drug and dilute it. It is used but it does not loss the pharmacological action of drugs.

 

 Analog:

 analog is the last step of drug molecule Optimisation. Analog is a compound, which structure is similar to another compound structure and by the replacement of another compound the drug can be optimised, but the Pharmacology of the drugs should be same and effective.

 

What is crystal and amorphous?

 crystal: crystal is a solid substance and which atomic level has a specific pattern or arrangement is called crystal.

 the example of Crystal: NaCl, sugar.

 Amorphous: Amorphous is a Latin word which “a” means no and morphous mean shape. So Amorphous is a substance  charactris where have not specific from of Shape. Amorphous have a low or no follow properties and so we cannot make it tablet.

 the example of amorphous:

• metallic glasses
• polymers.

What is powder flow properties? why it is important?

 Powder flow properties: The properties of the Powder which is very helps flowing the Powder is called powder flow properties.

 The importance of flow properties:

 -Important on manufacturing efficacy.

 - Impact quality.

 

How will you determind powder flow properties?

 There are some method or process to determined Powder flow propertie.

1) take the Powder into a funal and various with angle and follow them, by the method we can determind the Powder flow properties.

2) pescent compressive.

 

Percent compressive is the process to determine follow availity- explain it.

percent compressive means the distance of particle tab density and initial density by tab density and multiplication of 100.

 Now,

 percent compressive=PT - P0 / PTx100

PT = particle tab density.

 P0  =particle  initial density.

 the example of flow ability of percent compressive:

compressiv	Flow ability
5-15	Excellent
12-16	Good
18-21	Fair possible
23-35	poor
35-38	Very poor
>40	Very very poor

The compressibility index is inversely related to flowability. The greater the compressibility of a particulate solid, the lower its ability to flow. A powder having a compressibility index lesser than 20% is considered to have good flowability.

 what is co-solvent? what its example an important?

 co-solvent: the substance which can increase the solubility of the materials.

 the example of co-solvents:

-propyle glycol

 

 The important of co-solvent:

1) easily increase the solubility.

 example: prepare Paracetamol 120/ 100 ml of oral solution. we need propyle glycol is used as main co-solvents.

 

 what is partition coefficient? write about its important.

 partition coefficient = the soluble of API In an inorganic solvent / the soluble of API in organic solvent.

 The importance:

1) To determined the drug rate of absorption.

2) To determine the drug rate of distribution.

3) Drug stability.

What is Dissolution? Why it is important?

Dissolution is the process by which drug particles dissolve in body fluids.

Dissolution is an important step during pre-formulation studies because the rate of drug dissolution direct impact on bioavailability and drug delivery aspects . Any change in drug dissolution will significantly affect the bioavailability. 

Important:

1)Tube repair ophthalmic solution.

2) controlled drug quality .

What is the significant of pre- formulation in term of generating formulation of different dosage forms?

Mainly by the term of dosage form we know the form of API, and by the term of pre-formulation we know the before steps of preparation of drugs.

 only by the pre-formulation we are about to know the physical and chemical properties of a drug. According to the physical and chemical properties of drug we can make them in different dosages from. To prepare different dosages from the determination of physical and chemical properties are very important and these properties are discussed in the pre-formulation. so period to development of dosages from with new drug candidate. it is essential that some fundamental physicochemical properties of new drug molecule are determined. The information may dectate many of subsequent event and possible approaches in formulation development.

 so there are highly significant of pre-formulation in term of generating formulation of different dosage forms.

 

Why we need flow properties of molecule in preformulation?

 properties is a basic properties of molecule. By the information of flow properties of a molecule, we can understand on which dosage form we will make the drug. flow properties are mostly related with formulation of tablet and capsule. Efficient flow of drug substance powder in needed for effective tablet formulation. If one molecule have poor flow ability then the molecule have to optimise or by the molecule we cannot make tablet dosage from but we can make solution or liquid dosage form. compressibility is the indicator of ability.