Legitimate Pharmaceutical Preparations

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The Controlled Substances Act (CSA) of 1970 created a closed system for the production and distribution of legitimately manufactured controlled substances. The CSA includes contingencies to regulate the domestic commerce, importation, and exportation of these pharmaceutical preparations. Even with all of the controls that are in place, legitimate pharmaceuticals intended to help those in need are diverted onto the illegitimate market. Most of the diversion of these pharmaceuticals occurs at the retail rather than the wholesale level.

The analysis of pharmaceutical preparations in the forensic science laboratory is one of the most straightforward types of analysis. These samples are usually recognizable by their labels which usually include the manufacturers' logo and name. There are some samples that even have the name of the product inscribed on the tablet or capsule. In those instances where the manufacturer's logo is not recognized, the Physician's Desk Reference (PDR) is a readily available source of information which includes photographs and descriptions of the product along with information of the formulation. Another source of this information is the Logo Index for Tablets and Capsules.1 This particular text lists data including inscriptions on most known products including generics. After the tablet or capsule has been tentatively identified in a reference text, it is the responsibility of the forensic chemist to conduct a series of analyses to verify the presence of a controlled substance. This verification process will usually consist of many of the same analytical processes utilized in the analysis and evaluation of any controlled substance.

1.5.1 benzodiazepines

The benzodiazepines form one of the largest classes of abused pharmaceuticals. These products are sedative/hypnotics, tranquilizers, and anti-anxiety drugs and they produce a calming effect and are often prescribed as tranquilizers. The drugs in this class are numerous and are included under Schedule IV control because while they do have a potential for abuse, there are recognized medical benefits that are both physiological and psychological. The most frequently diverted and abused benzodiazepines are alprazolam (Xanax®) and diazepam (Valium®). Other frequently abused benzodiazepines are lorazepam (Activan®), triazolam (Halcion®), chlordiaz-epoxide (Librium®), flurazepam (Dalmane®), and temazepam (Restoril®). Another phenomenon that has been noted for several years is the abuse of legitimate pharmaceuticals in conjunction with illicit controlled substances. Clonazepam (Klonipin®) is just such a product. It is an anxiety reducer that is used in combination with methadone and heroin.

There has been a recent influx of flunitrazepam (Rohypnol®) into the Gulf Coast and other areas of the U.S. This product is a benzodiazepine manufactured principally in Colombia, Mexico, and Switzerland. It is also manufactured in lesser amounts in Argentina, Brazil, Peru, Uruguay, and Venezuela. It is neither manufactured nor marketed legally in the U.S. This is a powerful drug reported to be 7 to 10 times more potent than diazepam.

1.5.2 other central nervous system depressants

The oldest of the synthetic sleep inducing drugs dates back to 1862. Chloral hydrate is marketed as a soft gelatinous capsule under the name Noctec® , and controlled under Schedule V. Its popularity declined after the introduction of barbiturates. Barbiturates are the drugs prescribed most frequently to induce sedation. Roughly 15 derivatives of barbituric acid are currently in use to calm nervous conditions. In larger doses they are used to induce sleep.

The actions of barbiturates fall into four categories. Some of the ultrashort acting barbiturates are hexobarbital (Sombulex®), methohexital (Brevital®), thiamylal (Surital®), and thio-

Figure 1.5.2 Clandestine laboratory synthesis of methaqualone.

pental (Pentothal®). Short-acting and intermediate-acting barbiturates include pentobarbital (Nembutal®), secobarbital (Seconal®), and amobarbital (Amytal®). These three drugs have been among the most abused barbituric acid derivatives. Also included in these categories but not as abused are butabarbital (Butisol®), talbutal (Lotusate®), and aprobarbital (Alurate®). The last category is the long-acting barbiturates. These drugs are used medicinally as sedatives, hypnotics, and anticonvulsants. The group includes phenobarbital (Luminal®), mephobarbital or methylphenobarbital (Mebaral®), and metharbital (Gemonil®).

Three other CNS depressants that have been marketed as legitimate pharmaceutical preparations and have a history of abuse include glutethimide (Doriden®), methaqualone (Quaalude®, Parest®, Mequin®, Optimil®, Somnafac®, Sopor®, and Mandrax®), and meprobam-ate (Miltown®, Equanil®, and SK-Bamate®). The route for the clandestine synthesis of methaqualone is shown in Figure 1.5.2.

1.5.3 narcotic analgesics

When one thinks of opium-like compounds, morphine and heroin immediately come to mind. However, there is another subset of this class of compounds which includes pharmaceutical preparations used to relieve pain and are purchased legitimately or illegitimately from a pharmacy with a prescription. Frequently used pharmaceutical opiates include oxycodone (Percodan®), hydromorphone (Dilaudid®), hydrocodone (Tussionex® and Vicodin®), pentazocine (Talwin®), and codeine combinations such as Tylenol® with Codeine and Empirin® with Codeine. All of these compounds are addictive.

Along with Tylenol® with Codeine and Empirin® with Codeine, which are Schedule III controlled substances, codeine is also available in combination with another controlled substance (butalbital) and sold under the trade name of Fiorinal® with Codeine. It is available with acetaminophen in Phenaphen®. Codeine is available in liquid preparations under the manufacturers' names Cosanyl®, Robitussin A-C®, Cheracol®, Cerose®, and Pediacof®. Because of the amounts of codeine in these preparations, they are controlled under Schedule V. There are also pharmaceutical codeine tablets which contain no drug other than codeine and are controlled under Schedule II.

While the compounds listed above are considered opiates, there is another class of compounds also classified as narcotic, but with synthetic origins. Meperidine (Demerol®) is one of the most widely used analgesics for the relief of pain. Methadone (Amidone® and Dolophine®) is another of these synthetic narcotics. It was synthesized during World War II by German scientists because of a morphine shortage. Although it is chemically unlike morphine or heroin, it produces many of the same effects and is often used to treat narcotic addictions.

Dextropropoxyphene is one of those drugs which falls into one of two controlled substance schedules. When marketed in dosage form under the trade names Darvon®, Darvocet®, Dolene®, or Propacet®, dextropropoxyphene is a Schedule IV controlled substance. However, when marketed in bulk non-dosage forms, dextropropoxyphene is a Schedule II controlled substance. The significance here is that the penalties for possession of a Schedule II controlled substance are usually much greater than for possession of a Schedule IV controlled substance.

1.5.4 central nervous system stimulants

Amphetamine (Benzedrine® and Biphetamine®), dextroamphetamine (DexedrineR), and meth-amphetamine (Desoxyn®) are three of the best known CNS stimulants and were prescribed for many years to treat narcolepsy. At one time, these drugs were sold over the counter without a prescription. For many years these drugs were sold as appetite suppressants. Their availability in the form of prescription drugs has all but been eliminated except under the close scrutiny of a physician. However, the clandestine laboratory production of methamphetamine in the forms of a powder or granular material has been one of the major problems facing law enforcement personnel in the past 20 or so years in the U.S.

Phenmetrazine (Preludin®) and methylphenidate (Ritalin®) are two other CNS stimulants which have patterns of abuse similar to the amphetamine and methamphetamine products. In recent years, a number of pharmaceutical products have appeared on the market as appetite suppressants and as replacements for the amphetamines. These anorectic drugs include benzphetamine (Didrex®), chlorphentermine (Pre-Sate®), clortermine (Voranil®), diethylpropion (Tenuate® and Tepanil®), fenfluramine (Pondimin®), mazindol (Sanorex® and Mazanor®), phendimetrazine (Plegine®, Bacarate®, Melifat®, Statobex®, and Tanorex®), and phentermine (Ionamin® , Fastin®, and Adipex-P®).

1.5.5 identifying generic products

There are a number of generic products on the market which are legitimate pharmaceutical preparations. These products will usually contain the active ingredient of the brand name product, but at the same time have a different formulation in the way of diluents and binders. These products are cataloged in various publications. When these products are encountered in the forensic science laboratory, the analyst will usually make a preliminary identification using one of the many publications listing the tablet or capsule's description and the code number that appears in the face of the product. This "preliminary" identification affords a starting point in the analytical process. The analyst will then proceed using the standard chemical techniques and instrumental methods to make an independent identification.

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